Trial Outcomes & Findings for Individual Differences in the Response to Drugs (NCT NCT02485158)

NCT ID: NCT02485158

Last Updated: 2016-11-29

Results Overview

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration

Results posted on

2016-11-29

Participant Flow

Healthy social drinkers were recruited from the Chicago area through flyers and online advertisements, from June 2013 through February 2014.

Participant milestones

Participant milestones
Measure
Healthy Adult Volunteers
24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
Overall Study
STARTED
28
Overall Study
COMPLETED
24
Overall Study
NOT COMPLETED
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Healthy Adult Volunteers
24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
Overall Study
Withdrawal by Subject
3
Overall Study
expected drug side effect
1

Baseline Characteristics

Individual Differences in the Response to Drugs

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Healthy Adult Volunteers
n=28 Participants
All healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
Age, Continuous
24.6 years
STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male
Female
16 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration

Population: Participants who completed all sessions

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration
DEQ Feel
4.79 units on a scale
Standard Deviation 7.22
12.83 units on a scale
Standard Deviation 18.78
11.08 units on a scale
Standard Deviation 21.09
12.17 units on a scale
Standard Deviation 19.90
9.38 units on a scale
Standard Deviation 11.12
4.5 units on a scale
Standard Deviation 13.16
Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration
DEQ Like
16.08 units on a scale
Standard Deviation 27.47
18.67 units on a scale
Standard Deviation 28.81
11.75 units on a scale
Standard Deviation 21.84
9.0 units on a scale
Standard Deviation 18.42
10.04 units on a scale
Standard Deviation 17.90
9.67 units on a scale
Standard Deviation 24.14
Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration
DEQ Dislike
4.21 units on a scale
Standard Deviation 9.43
11.71 units on a scale
Standard Deviation 20.35
12.38 units on a scale
Standard Deviation 23.77
10.71 units on a scale
Standard Deviation 18.75
11.0 units on a scale
Standard Deviation 20.60
0.83 units on a scale
Standard Deviation 2.24
Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration
DEQ High
3.29 units on a scale
Standard Deviation 6.06
8.83 units on a scale
Standard Deviation 16.31
10.58 units on a scale
Standard Deviation 21.85
6.96 units on a scale
Standard Deviation 18.44
5.5 units on a scale
Standard Deviation 10.43
3.67 units on a scale
Standard Deviation 9.40
Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration
DEQ More
14.21 units on a scale
Standard Deviation 25.26
13.5 units on a scale
Standard Deviation 25.24
6.54 units on a scale
Standard Deviation 13.71
5.63 units on a scale
Standard Deviation 12.59
3.71 units on a scale
Standard Deviation 7.66
11.0 units on a scale
Standard Deviation 25.32

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 30 minutes after drink administration.

Population: Participants who completed all sessions

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration
DEQ Feel
43.42 units on a scale
Standard Deviation 29.53
76.83 units on a scale
Standard Deviation 20.01
38.25 units on a scale
Standard Deviation 33.45
21.58 units on a scale
Standard Deviation 19.52
17.83 units on a scale
Standard Deviation 22.56
18.63 units on a scale
Standard Deviation 20.69
Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration
DEQ Like
53.88 units on a scale
Standard Deviation 34.49
45.08 units on a scale
Standard Deviation 28.43
28.75 units on a scale
Standard Deviation 30.05
16.63 units on a scale
Standard Deviation 22.89
14.38 units on a scale
Standard Deviation 20.78
25.29 units on a scale
Standard Deviation 28.76
Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration
DEQ Dislike
15.71 units on a scale
Standard Deviation 22.76
43.96 units on a scale
Standard Deviation 28.96
25.63 units on a scale
Standard Deviation 35.03
17.71 units on a scale
Standard Deviation 23.32
16.68 units on a scale
Standard Deviation 26.83
15.79 units on a scale
Standard Deviation 20.66
Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration
DEQ High
30.5 units on a scale
Standard Deviation 27.78
50.38 units on a scale
Standard Deviation 32.15
31.75 units on a scale
Standard Deviation 35.00
12.54 units on a scale
Standard Deviation 18.09
11.5 units on a scale
Standard Deviation 21.80
12.96 units on a scale
Standard Deviation 20.22
Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration
DEQ More
42.17 units on a scale
Standard Deviation 35.27
24.75 units on a scale
Standard Deviation 32.67
17.46 units on a scale
Standard Deviation 25.18
10.96 units on a scale
Standard Deviation 19.14
10.0 units on a scale
Standard Deviation 18.32
18.96 units on a scale
Standard Deviation 28.97

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 90 minutes after drink administration.

Population: Participants who completed all sessions

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration
DEQ Feel
34.92 units on a scale
Standard Deviation 24.75
61.21 units on a scale
Standard Deviation 24.02
31.54 units on a scale
Standard Deviation 31.41
16.46 units on a scale
Standard Deviation 18.97
12.75 units on a scale
Standard Deviation 18.74
13.17 units on a scale
Standard Deviation 19.05
Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration
DEQ Like
55.67 units on a scale
Standard Deviation 31.45
29.92 units on a scale
Standard Deviation 28.57
20.08 units on a scale
Standard Deviation 26.32
10.42 units on a scale
Standard Deviation 18.22
11.38 units on a scale
Standard Deviation 19.35
13.25 units on a scale
Standard Deviation 22.87
Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration
DEQ Dislike
16.54 units on a scale
Standard Deviation 21.60
50.46 units on a scale
Standard Deviation 26.47
23.25 units on a scale
Standard Deviation 29.72
17.54 units on a scale
Standard Deviation 26.16
15.33 units on a scale
Standard Deviation 24.85
15.96 units on a scale
Standard Deviation 24.91
Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration
DEQ High
27.92 units on a scale
Standard Deviation 24.57
41.83 units on a scale
Standard Deviation 30.74
29.21 units on a scale
Standard Deviation 32.78
6.83 units on a scale
Standard Deviation 12.47
7.25 units on a scale
Standard Deviation 13.50
7.58 units on a scale
Standard Deviation 12.65
Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration
DEQ More
50.21 units on a scale
Standard Deviation 36.06
25.88 units on a scale
Standard Deviation 35.11
16.54 units on a scale
Standard Deviation 23.69
6.54 units on a scale
Standard Deviation 15.33
7.71 units on a scale
Standard Deviation 16.59
12.88 units on a scale
Standard Deviation 21.88

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 120 minutes after drink administration.

Population: Participants who completed all sessions

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion
DEQ More
45.38 units on a scale
Standard Deviation 34.86
17.5 units on a scale
Standard Deviation 27.95
9.92 units on a scale
Standard Deviation 18.06
3.13 units on a scale
Standard Deviation 5.53
6.54 units on a scale
Standard Deviation 15.59
9.88 units on a scale
Standard Deviation 19.63
Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion
DEQ Feel
27.08 units on a scale
Standard Deviation 22.38
43.92 units on a scale
Standard Deviation 24.18
24.08 units on a scale
Standard Deviation 29.28
11.92 units on a scale
Standard Deviation 14.26
7.96 units on a scale
Standard Deviation 14.08
7.88 units on a scale
Standard Deviation 14.65
Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion
DEQ Like
43.75 units on a scale
Standard Deviation 36.08
23.79 units on a scale
Standard Deviation 25.61
18 units on a scale
Standard Deviation 27.26
7.04 units on a scale
Standard Deviation 13.90
4.83 units on a scale
Standard Deviation 11.49
8.67 units on a scale
Standard Deviation 16.86
Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion
DEQ Dislike
11.92 units on a scale
Standard Deviation 19.56
44.92 units on a scale
Standard Deviation 31.37
19.63 units on a scale
Standard Deviation 27.21
13.38 units on a scale
Standard Deviation 22.39
11.08 units on a scale
Standard Deviation 23.89
8.88 units on a scale
Standard Deviation 18.69
Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion
DEQ High
18.88 units on a scale
Standard Deviation 21.43
29.38 units on a scale
Standard Deviation 25.77
21.96 units on a scale
Standard Deviation 30.06
5.04 units on a scale
Standard Deviation 8.12
5.08 units on a scale
Standard Deviation 11.20
4.83 units on a scale
Standard Deviation 10.45

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 150 minutes after drink administration.

Population: Participants who completed all sessions

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration
DEQ Feel
19.79 units on a scale
Standard Deviation 17.72
30.83 units on a scale
Standard Deviation 22.52
18.63 units on a scale
Standard Deviation 25.28
5.83 units on a scale
Standard Deviation 10.72
4.63 units on a scale
Standard Deviation 10.48
4.63 units on a scale
Standard Deviation 7.80
Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration
DEQ Like
39.5 units on a scale
Standard Deviation 34.58
21.33 units on a scale
Standard Deviation 24.74
11.71 units on a scale
Standard Deviation 19.22
6.74 units on a scale
Standard Deviation 14.88
2.42 units on a scale
Standard Deviation 6.76
4.96 units on a scale
Standard Deviation 14.48
Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration
DEQ Dislike
11.25 units on a scale
Standard Deviation 20.64
40.75 units on a scale
Standard Deviation 32.31
17.79 units on a scale
Standard Deviation 26.78
8.09 units on a scale
Standard Deviation 21.80
4.29 units on a scale
Standard Deviation 13.84
6.42 units on a scale
Standard Deviation 15.69
Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration
DEQ High
16.33 units on a scale
Standard Deviation 18.68
20.46 units on a scale
Standard Deviation 23.70
14.75 units on a scale
Standard Deviation 20.27
2.87 units on a scale
Standard Deviation 4.48
2.13 units on a scale
Standard Deviation 4.83
1.96 units on a scale
Standard Deviation 4.56
Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration
DEQ More
44.08 units on a scale
Standard Deviation 34.63
12.58 units on a scale
Standard Deviation 24.39
9.38 units on a scale
Standard Deviation 18.95
2.87 units on a scale
Standard Deviation 10.55
5.04 units on a scale
Standard Deviation 12.75
6.21 units on a scale
Standard Deviation 15.19

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 180 minutes after drink administration.

Population: Participants who completed all sessions

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration
DEQ Feel
16.13 units on a scale
Standard Deviation 17.06
22.21 units on a scale
Standard Deviation 19.71
15.67 units on a scale
Standard Deviation 24.63
3.5 units on a scale
Standard Deviation 8.548
2.08 units on a scale
Standard Deviation 5.01
2.54 units on a scale
Standard Deviation 4.59
Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration
DEQ Like
31.08 units on a scale
Standard Deviation 34.86
9.04 units on a scale
Standard Deviation 14.29
7.33 units on a scale
Standard Deviation 15.82
2.54 units on a scale
Standard Deviation 11.23
1.75 units on a scale
Standard Deviation 7.56
4.0 units on a scale
Standard Deviation 12.47
Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration
DEQ Dislike
11.54 units on a scale
Standard Deviation 25.17
29.5 units on a scale
Standard Deviation 34.28
16.13 units on a scale
Standard Deviation 28.42
4.25 units on a scale
Standard Deviation 17.24
4.29 units on a scale
Standard Deviation 16.80
4.63 units on a scale
Standard Deviation 13.65
Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration
DEQ High
11.67 units on a scale
Standard Deviation 15.29
14.13 units on a scale
Standard Deviation 19.36
11.79 units on a scale
Standard Deviation 18.36
1.63 units on a scale
Standard Deviation 4.92
1.25 units on a scale
Standard Deviation 3.30
1.04 units on a scale
Standard Deviation 3.30
Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration
DEQ More
38.38 units on a scale
Standard Deviation 34.54
7.0 units on a scale
Standard Deviation 19.77
10.04 units on a scale
Standard Deviation 18.61
2.46 units on a scale
Standard Deviation 10.99
4.04 units on a scale
Standard Deviation 12.22
5.04 units on a scale
Standard Deviation 12.89

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 210 minutes after drink administration.

Population: Participants who completed all sessions

Drug effects will be measured using the Drug Effects Questionnaire (Fischman \& Foltin, 1991). The DEQ included 5 subscales; feeling, liking, and disliking the drug effect, feeling high, and wanting more of the drug. Each subscale ranged from 1(Not at all) to 100(Very much). The change in DFQ was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration
DEQ Feel
11.08 units on a scale
Standard Deviation 16.71
12.88 units on a scale
Standard Deviation 15.88
5.79 units on a scale
Standard Deviation 10.91
2.17 units on a scale
Standard Deviation 5.74
0.96 units on a scale
Standard Deviation 2.74
1.08 units on a scale
Standard Deviation 2.75
Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration
DEQ Like
18.38 units on a scale
Standard Deviation 31.38
7.33 units on a scale
Standard Deviation 14.62
4.88 units on a scale
Standard Deviation 10.41
1.96 units on a scale
Standard Deviation 7.04
0.25 units on a scale
Standard Deviation 0.74
4.38 units on a scale
Standard Deviation 13.73
Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration
DEQ High
6.25 units on a scale
Standard Deviation 9.88
9.21 units on a scale
Standard Deviation 15.84
4.96 units on a scale
Standard Deviation 11.02
0.33 units on a scale
Standard Deviation 1.05
0.83 units on a scale
Standard Deviation 1.76
0.42 units on a scale
Standard Deviation 1.32
Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration
DEQ More
32.5 units on a scale
Standard Deviation 31.84
4.54 units on a scale
Standard Deviation 17.72
8.79 units on a scale
Standard Deviation 17.04
2.25 units on a scale
Standard Deviation 8.19
3.83 units on a scale
Standard Deviation 12.09
6.17 units on a scale
Standard Deviation 14.65
Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration
DEQ Dislike
8.54 units on a scale
Standard Deviation 24.16
22.71 units on a scale
Standard Deviation 30.79
6.83 units on a scale
Standard Deviation 15.46
7.46 units on a scale
Standard Deviation 23.16
1.29 units on a scale
Standard Deviation 3.82
4.54 units on a scale
Standard Deviation 15.14

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 30 minutes after capsule administration and before drink administration

Population: Participants who completed all sessions

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after capsule administration and before drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration
ARC MBG
-0.58 units on a scale
Standard Deviation 1.44
-0.29 units on a scale
Standard Deviation 1.27
-0.71 units on a scale
Standard Deviation 1.88
-0.58 units on a scale
Standard Deviation 0.65
-0.67 units on a scale
Standard Deviation 1.46
0.33 units on a scale
Standard Deviation 1.37
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration
ARC M
0.08 units on a scale
Standard Deviation 1.06
0.83 units on a scale
Standard Deviation 1.81
0.42 units on a scale
Standard Deviation 1.32
0.5 units on a scale
Standard Deviation 1.25
0.33 units on a scale
Standard Deviation 1.05
0.42 units on a scale
Standard Deviation 1.18
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration
ARC A
-0.17 units on a scale
Standard Deviation 0.92
0.25 units on a scale
Standard Deviation 1.33
-0.04 units on a scale
Standard Deviation 1.16
-0.25 units on a scale
Standard Deviation 0.61
-0.17 units on a scale
Standard Deviation 1.2
0.54 units on a scale
Standard Deviation 0.88
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration
ARC LSD
0.13 units on a scale
Standard Deviation 0.85
0.33 units on a scale
Standard Deviation 0.82
0.38 units on a scale
Standard Deviation 1.69
0.13 units on a scale
Standard Deviation 0.99
0.08 units on a scale
Standard Deviation 0.97
-0.17 units on a scale
Standard Deviation 0.64
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration
ARC BG
-0.46 units on a scale
Standard Deviation 1.02
-0.75 units on a scale
Standard Deviation 1.67
-0.79 units on a scale
Standard Deviation 2.0
-1.17 units on a scale
Standard Deviation 1.52
-0.92 units on a scale
Standard Deviation 1.21
0.25 units on a scale
Standard Deviation 1.03
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration
ARC PCAG
0.58 units on a scale
Standard Deviation 1.21
1.29 units on a scale
Standard Deviation 2.39
2.92 units on a scale
Standard Deviation 2.73
1.96 units on a scale
Standard Deviation 2.44
0.92 units on a scale
Standard Deviation 1.61
0.42 units on a scale
Standard Deviation 1.02

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 30 minutes after drink administration

Population: Participants who completed all sessions

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 30 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration
ARC A
2.88 units on a scale
Standard Deviation 2.80
1.92 units on a scale
Standard Deviation 2.64
0.17 units on a scale
Standard Deviation 0.96
0 units on a scale
Standard Deviation 0.93
-0.33 units on a scale
Standard Deviation 1.61
0.71 units on a scale
Standard Deviation 1.40
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration
ARC MBG
3.71 units on a scale
Standard Deviation 4.59
1.38 units on a scale
Standard Deviation 4.79
-0.54 units on a scale
Standard Deviation 3.04
0 units on a scale
Standard Deviation 1.77
-1.17 units on a scale
Standard Deviation 2.75
0.88 units on a scale
Standard Deviation 3.26
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration
ARC PCAG
-1 units on a scale
Standard Deviation 1.89
3.71 units on a scale
Standard Deviation 4.29
2.96 units on a scale
Standard Deviation 3.33
2.25 units on a scale
Standard Deviation 3.55
1.54 units on a scale
Standard Deviation 3.24
1.13 units on a scale
Standard Deviation 2.35
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration
ARC M
3.21 units on a scale
Standard Deviation 2.73
3.42 units on a scale
Standard Deviation 2.22
2.04 units on a scale
Standard Deviation 2.56
0.42 units on a scale
Standard Deviation 0.93
0.29 units on a scale
Standard Deviation 1.16
0.96 units on a scale
Standard Deviation 1.78
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration
ARC LSD
1.13 units on a scale
Standard Deviation 2.03
2.63 units on a scale
Standard Deviation 2.32
1.54 units on a scale
Standard Deviation 2.47
0.33 units on a scale
Standard Deviation 1.09
0.29 units on a scale
Standard Deviation 1.12
0.13 units on a scale
Standard Deviation 1.23
Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration
ARC BG
1.63 units on a scale
Standard Deviation 2.28
-0.88 units on a scale
Standard Deviation 3.00
-1.38 units on a scale
Standard Deviation 1.64
-0.83 units on a scale
Standard Deviation 1.31
-0.96 units on a scale
Standard Deviation 1.99
0.04 units on a scale
Standard Deviation 1.46

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 90 minutes after drink administration

Population: Participants who completed all sessions

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects. The change in ARCI was assessed by the difference in measurements between baseline and 90 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration
ARC A
2.96 units on a scale
Standard Deviation 2.49
0.29 units on a scale
Standard Deviation 2.44
0 units on a scale
Standard Deviation 1.22
-0.33 units on a scale
Standard Deviation 0.76
-0.58 units on a scale
Standard Deviation 1.28
-0.08 units on a scale
Standard Deviation 1.02
Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration
ARC MBG
3.67 units on a scale
Standard Deviation 4.86
-0.38 units on a scale
Standard Deviation 2.45
-0.83 units on a scale
Standard Deviation 2.55
-0.29 units on a scale
Standard Deviation 0.86
-1.29 units on a scale
Standard Deviation 2.93
-0.13 units on a scale
Standard Deviation 0.95
Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration
ARC LSD
1.08 units on a scale
Standard Deviation 1.89
1.79 units on a scale
Standard Deviation 1.93
1.42 units on a scale
Standard Deviation 2.69
-0.04 units on a scale
Standard Deviation 0.95
0.29 units on a scale
Standard Deviation 1.12
0.08 units on a scale
Standard Deviation 0.93
Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration
ARC PCAG
-1.21 units on a scale
Standard Deviation 2.17
6.21 units on a scale
Standard Deviation 2.92
3.54 units on a scale
Standard Deviation 3.68
2.67 units on a scale
Standard Deviation 2.96
1.92 units on a scale
Standard Deviation 3.22
1.58 units on a scale
Standard Deviation 1.91
Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration
ARC M
2.63 units on a scale
Standard Deviation 2.46
2.25 units on a scale
Standard Deviation 2.51
2.04 units on a scale
Standard Deviation 2.63
0.42 units on a scale
Standard Deviation 0.97
0.13 units on a scale
Standard Deviation 0.80
0.29 units on a scale
Standard Deviation 0.62
Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration
ARC BG
2.17 units on a scale
Standard Deviation 2.39
-2.54 units on a scale
Standard Deviation 2.40
-1.71 units on a scale
Standard Deviation 2.03
-1.29 units on a scale
Standard Deviation 1.63
-1.13 units on a scale
Standard Deviation 1.57
-0.67 units on a scale
Standard Deviation 1.46

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 120 minutes after drink administration

Population: Participants who completed all sessions

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 120 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration
ARC A
2.17 units on a scale
Standard Deviation 2.06
-0.33 units on a scale
Standard Deviation 1.34
-0.08 units on a scale
Standard Deviation 1.21
-0.17 units on a scale
Standard Deviation 0.70
-0.71 units on a scale
Standard Deviation 1.37
-0.04 units on a scale
Standard Deviation 0.86
Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration
ARC MBG
3.33 units on a scale
Standard Deviation 4.35
-1.13 units on a scale
Standard Deviation 2.13
-0.96 units on a scale
Standard Deviation 2.60
-0.125 units on a scale
Standard Deviation 0.85
-1.29 units on a scale
Standard Deviation 2.97
-0.08 units on a scale
Standard Deviation 0.65
Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration
ARC LSD
0.38 units on a scale
Standard Deviation 1.93
0.79 units on a scale
Standard Deviation 1.28
1 units on a scale
Standard Deviation 2.83
-0.13 units on a scale
Standard Deviation 1.15
0.04 units on a scale
Standard Deviation 1.16
-0.08 units on a scale
Standard Deviation 0.93
Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration
ARC BG
1.67 units on a scale
Standard Deviation 2.12
-2.04 units on a scale
Standard Deviation 1.73
-1.54 units on a scale
Standard Deviation 1.64
-1 units on a scale
Standard Deviation 1.35
-0.83 units on a scale
Standard Deviation 1.55
-0.38 units on a scale
Standard Deviation 1.58
Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration
ARC PCAG
-1.08 units on a scale
Standard Deviation 2.02
5.46 units on a scale
Standard Deviation 2.93
2.88 units on a scale
Standard Deviation 3.49
1.71 units on a scale
Standard Deviation 2.65
1.63 units on a scale
Standard Deviation 2.76
1.08 units on a scale
Standard Deviation 1.98
Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration
ARC M
1.83 units on a scale
Standard Deviation 2.46
1.08 units on a scale
Standard Deviation 1.56
1.42 units on a scale
Standard Deviation 2.04
0.25 units on a scale
Standard Deviation 0.85
-0.04 units on a scale
Standard Deviation 0.86
0.17 units on a scale
Standard Deviation 0.56

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 150 minutes after drink administration

Population: Participants who completed all sessions

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 150 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration
ARC A
2.29 units on a scale
Standard Deviation 2.61
-0.54 units on a scale
Standard Deviation 1.14
-0.17 units on a scale
Standard Deviation 1.63
-0.13 units on a scale
Standard Deviation 0.69
-0.54 units on a scale
Standard Deviation 1.47
-0.08 units on a scale
Standard Deviation 0.83
Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration
ARC MBG
2.96 units on a scale
Standard Deviation 4.39
-1.54 units on a scale
Standard Deviation 1.96
-0.96 units on a scale
Standard Deviation 2.39
0.13 units on a scale
Standard Deviation 0.76
-1.25 units on a scale
Standard Deviation 2.88
-0.08 units on a scale
Standard Deviation 0.88
Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration
ARC LSD
0.5 units on a scale
Standard Deviation 1.59
0.79 units on a scale
Standard Deviation 1.35
0.58 units on a scale
Standard Deviation 2.22
0.09 units on a scale
Standard Deviation 1.08
-0.13 units on a scale
Standard Deviation 1.03
-0.17 units on a scale
Standard Deviation 0.82
Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration
ARC BG
1.75 units on a scale
Standard Deviation 2.31
-2.04 units on a scale
Standard Deviation 1.65
-1.29 units on a scale
Standard Deviation 1.86
-0.43 units on a scale
Standard Deviation 1.31
-0.67 units on a scale
Standard Deviation 1.24
-0.42 units on a scale
Standard Deviation 1.28
Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration
ARC PCAG
-1 units on a scale
Standard Deviation 1.64
5.46 units on a scale
Standard Deviation 2.95
2.58 units on a scale
Standard Deviation 3.16
0.65 units on a scale
Standard Deviation 2.17
1.58 units on a scale
Standard Deviation 2.96
0.79 units on a scale
Standard Deviation 1.79
Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration
ARC M
1.54 units on a scale
Standard Deviation 1.91
0.75 units on a scale
Standard Deviation 1.33
0.83 units on a scale
Standard Deviation 1.83
0.22 units on a scale
Standard Deviation 0.74
-0.21 units on a scale
Standard Deviation 0.78
0.08 units on a scale
Standard Deviation 0.41

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 180 minutes after drink administration

Population: Participants who completed all sessions

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 180 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration
ARC A
1.58 units on a scale
Standard Deviation 2.26
-0.75 units on a scale
Standard Deviation 1.19
-0.21 units on a scale
Standard Deviation 1.44
-0.04 units on a scale
Standard Deviation 0.91
-0.33 units on a scale
Standard Deviation 1.69
-0.17 units on a scale
Standard Deviation 1.13
Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration
ARC MBG
1.92 units on a scale
Standard Deviation 4.03
-1.29 units on a scale
Standard Deviation 1.88
-0.67 units on a scale
Standard Deviation 2.37
0.33 units on a scale
Standard Deviation 1.24
-1.08 units on a scale
Standard Deviation 3.01
-0.17 units on a scale
Standard Deviation 0.82
Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration
ARC LSD
0.46 units on a scale
Standard Deviation 1.91
0.54 units on a scale
Standard Deviation 1.02
0.54 units on a scale
Standard Deviation 1.82
0.04 units on a scale
Standard Deviation 1.04
-0.04 units on a scale
Standard Deviation 0.81
0.04 units on a scale
Standard Deviation 0.95
Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration
ARC BG
1.13 units on a scale
Standard Deviation 2.15
-1.5 units on a scale
Standard Deviation 1.47
-1.29 units on a scale
Standard Deviation 1.78
-0.33 units on a scale
Standard Deviation 1.13
-0.38 units on a scale
Standard Deviation 1.41
-0.29 units on a scale
Standard Deviation 1.20
Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration
ARC PCAG
-0.46 units on a scale
Standard Deviation 1.93
3.63 units on a scale
Standard Deviation 3.01
2.13 units on a scale
Standard Deviation 3.43
0.21 units on a scale
Standard Deviation 2.50
0.71 units on a scale
Standard Deviation 2.73
0.42 units on a scale
Standard Deviation 1.59
Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration
ARC M
1.21 units on a scale
Standard Deviation 1.59
0.08 units on a scale
Standard Deviation 1.02
0.71 units on a scale
Standard Deviation 1.94
0.13 units on a scale
Standard Deviation 0.68
-0.13 units on a scale
Standard Deviation 0.74
-0.08 units on a scale
Standard Deviation 0.28

PRIMARY outcome

Timeframe: Measured 15 minutes prior to capsule administration and 210 minutes after drink administration

Population: Participants who completed all sessions

Specific drug effects will be measured using the Addiction Research Center Inventory (Martin et al. 1971). The ARCI measures effects specific to drug classes, including the effects of AMP-like drugs (A scale, 0 to 11), morphine and benzedrine like drugs (MBG scale, 0 to 14), lysergic acid-like drugs (LSD scale, 0 to 14), benzedrine-like drugs (BG scale, 0 to 13), pentobarbital-chlorpromazine and ALC-like drugs (PCAG scale, 0 to 15), and cannabis-like drugs (M scale, 0 to 12). We used this questionnaire as a manipulation check to ensure that the drugs produced their typical drug-specific effects in this study. For example, zero value of A sacle would be minimum report of amphetamine-like drug effects, and 11 would be maximum report of amphetamine-like effects.The change in ARCI was assessed by the difference in measurements between baseline and 210 minutes after drink administration. Baseline was measure 15 minutes prior to capsule administration.

Outcome measures

Outcome measures
Measure
AMP Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
ALC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
THC Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
AMP Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
ALC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
THC Placebo Arm
n=24 Participants
All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration
ARC LSD
0.63 units on a scale
Standard Deviation 1.79
0.33 units on a scale
Standard Deviation 0.92
0.54 units on a scale
Standard Deviation 1.22
0.25 units on a scale
Standard Deviation 0.90
1.67 units on a scale
Standard Deviation 0.87
0.04 units on a scale
Standard Deviation 1.04
Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration
ARC BG
0.83 units on a scale
Standard Deviation 1.61
-1.25 units on a scale
Standard Deviation 1.39
-0.83 units on a scale
Standard Deviation 1.40
-0.17 units on a scale
Standard Deviation 0.82
-0.38 units on a scale
Standard Deviation 1.06
-0.13 units on a scale
Standard Deviation 1.48
Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration
ARC PCAG
-0.29 units on a scale
Standard Deviation 2.10
3.17 units on a scale
Standard Deviation 3.17
1.04 units on a scale
Standard Deviation 1.76
-0.29 units on a scale
Standard Deviation 1.43
0.21 units on a scale
Standard Deviation 2.55
0.13 units on a scale
Standard Deviation 1.68
Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration
ARC M
0.96 units on a scale
Standard Deviation 1.97
0.08 units on a scale
Standard Deviation 0.97
0.21 units on a scale
Standard Deviation 0.72
0 units on a scale
Standard Deviation 0.42
-0.17 units on a scale
Standard Deviation 0.70
-0.08 units on a scale
Standard Deviation 0.28
Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration
ARC A
1.0 units on a scale
Standard Deviation 1.93
-0.71 units on a scale
Standard Deviation 1.20
-0.46 units on a scale
Standard Deviation 1.06
-0.17 units on a scale
Standard Deviation 0.82
-0.54 units on a scale
Standard Deviation 1.50
0.08 units on a scale
Standard Deviation 1.21
Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration
ARC MBG
1.38 units on a scale
Standard Deviation 3.31
-1.17 units on a scale
Standard Deviation 2.08
-0.88 units on a scale
Standard Deviation 1.92
0.13 units on a scale
Standard Deviation 1.15
-0.79 units on a scale
Standard Deviation 2.95
0.04 units on a scale
Standard Deviation 0.86

Adverse Events

Healthy Adult Volunteers

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Healthy Adult Volunteers
n=28 participants at risk
24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
Gastrointestinal disorders
vomiting from alcohol dose
3.6%
1/28 • Number of events 1 • During study only (1 Day)

Additional Information

Dr. Harriet de Wit

University of Chicago

Phone: 773-702-1537

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place