Trial Outcomes & Findings for Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer (NCT NCT02383043)
NCT ID: NCT02383043
Last Updated: 2019-04-11
Results Overview
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
18 participants
Primary outcome timeframe
9 choice trials per cocaine dose level with each trial separated by 30 minutes
Results posted on
2019-04-11
Participant Flow
Participant milestones
| Measure |
Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine
Cocaine choice during placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine maintenance
Placebo and Cocaine
Placebo and Sustained Release d-Amphetamine
|
30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine
Cocaine choice during 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine maintenance
Placebo and Cocaine
Placebo Sustained Release d-Amphetamine maintenance
|
30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo
Cocaine choice during 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo maintenance
Placebo and Cocaine
Placebo and Sustained Release d-Amphetamine
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
5
|
4
|
|
Overall Study
COMPLETED
|
7
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
Baseline characteristics by cohort
| Measure |
Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine
n=7 Participants
Cocaine choice during Placebo, 30 mg d-Amphetamine, 60 mg d-Amphetamine maintenance
Placebo and Cocaine
Placebo and Sustained Release d-Amphetamine
|
30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine
n=5 Participants
Cocaine choice during 30 mg d-Amphetamine, Placebo, 60 mg d-Amphetamine maintenance
Placebo and Cocaine
Placebo and Sustained Release d-Amphetamine
|
30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo
n=4 Participants
Cocaine choice during 30 mg d-Amphetamine, 60 mg d-Amphetamine, Placebo maintenance
Placebo and Cocaine
Placebo and Sustained Release d-Amphetamine
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/Latino Black Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/Latino White Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/Latino Black Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/Latino White Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino Black Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 9 choice trials per cocaine dose level with each trial separated by 30 minutesThe reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance.
Outcome measures
| Measure |
30 mg d-Amphetamine
n=16 Participants
Cocaine choice during 30 mg d-amphetamine maintenance
Placebo and Cocaine
Sustained Release d-Amphetamine
|
Placebo Treatment
n=16 Participants
Cocaine choice during placebo maintenance
Placebo and Cocaine
Placebo
|
60 mg d-Amphetamine
n=16 Participants
Cocaine choice during 60 mg d-amphetamine maintenance
Placebo and Cocaine
Sustained Release d-Amphetamine
|
|---|---|---|---|
|
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
Placebo Cocaine
|
0.06 cocaine choices
Standard Error 0.06
|
0.94 cocaine choices
Standard Error 0.35
|
0.75 cocaine choices
Standard Error 0.36
|
|
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
3 mg/70 kg Cocaine
|
0.88 cocaine choices
Standard Error 0.43
|
2.50 cocaine choices
Standard Error 0.89
|
0.56 cocaine choices
Standard Error 0.26
|
|
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
10 mg/70 kg Cocaine
|
1.88 cocaine choices
Standard Error 0.50
|
5.13 cocaine choices
Standard Error 0.93
|
1.50 cocaine choices
Standard Error 0.51
|
|
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
30 mg/70kg Cocaine
|
4.69 cocaine choices
Standard Error 0.89
|
6.00 cocaine choices
Standard Error 0.99
|
5.19 cocaine choices
Standard Error 0.95
|
Adverse Events
Medical Safety Session
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
30 mg d-Amphetamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
60 mg d-Amphetamine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Medical Safety Session
n=18 participants at risk
Experimenter administered Placebo and Cocaine delivery. d-Amphetamine maintenance not yet initiated.
|
Placebo
n=18 participants at risk
Cocaine choice during placebo d-Amphetamine maintenance
Placebo and Cocaine
|
30 mg d-Amphetamine
n=17 participants at risk
Cocaine choice during 30 mg d-Amphetamine maintenance
Placebo and Cocaine
|
60 mg d-Amphetamine
n=17 participants at risk
Cocaine choice during 60 mg d-Amphetamine maintenance
Placebo and Cocaine
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Chest pain
|
0.00%
0/18 • 33 days per subject.
Adverse event reporting consists of each the duration of each d-amphetamine maintenance condition as well as during the conduct of a medical safety session in which cocaine doses are administered prior to initiation of d-amphetamine maintenance.
|
0.00%
0/18 • 33 days per subject.
Adverse event reporting consists of each the duration of each d-amphetamine maintenance condition as well as during the conduct of a medical safety session in which cocaine doses are administered prior to initiation of d-amphetamine maintenance.
|
0.00%
0/17 • 33 days per subject.
Adverse event reporting consists of each the duration of each d-amphetamine maintenance condition as well as during the conduct of a medical safety session in which cocaine doses are administered prior to initiation of d-amphetamine maintenance.
|
5.9%
1/17 • Number of events 1 • 33 days per subject.
Adverse event reporting consists of each the duration of each d-amphetamine maintenance condition as well as during the conduct of a medical safety session in which cocaine doses are administered prior to initiation of d-amphetamine maintenance.
|
|
Gastrointestinal disorders
Nausea and vomiting
|
5.6%
1/18 • Number of events 1 • 33 days per subject.
Adverse event reporting consists of each the duration of each d-amphetamine maintenance condition as well as during the conduct of a medical safety session in which cocaine doses are administered prior to initiation of d-amphetamine maintenance.
|
0.00%
0/18 • 33 days per subject.
Adverse event reporting consists of each the duration of each d-amphetamine maintenance condition as well as during the conduct of a medical safety session in which cocaine doses are administered prior to initiation of d-amphetamine maintenance.
|
0.00%
0/17 • 33 days per subject.
Adverse event reporting consists of each the duration of each d-amphetamine maintenance condition as well as during the conduct of a medical safety session in which cocaine doses are administered prior to initiation of d-amphetamine maintenance.
|
0.00%
0/17 • 33 days per subject.
Adverse event reporting consists of each the duration of each d-amphetamine maintenance condition as well as during the conduct of a medical safety session in which cocaine doses are administered prior to initiation of d-amphetamine maintenance.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place