Trial Outcomes & Findings for The Effects of Buprenorphine on Responses to Verbal Tasks (NCT NCT01860287)
NCT ID: NCT01860287
Last Updated: 2019-08-01
Results Overview
The Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0 -100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
COMPLETED
EARLY_PHASE1
48 participants
End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shown
2019-08-01
Participant Flow
Participant milestones
| Measure |
Placebo Group
Healthy volunteers receive placebo
|
0.2 Buprenorphine
Healthy volunteers will receive 0.2 mg of buprenorphine
|
0.4 mg Buprenorphine
Healthy volunteers will receive 0.4 mg of buprenorphine
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
15
|
15
|
|
Overall Study
COMPLETED
|
18
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effects of Buprenorphine on Responses to Verbal Tasks
Baseline characteristics by cohort
| Measure |
Placebo Group
n=18 Participants
Healthy volunteers receive placebo during session (within-subjects design).
Placebo: This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo
|
Buprenorphine (0.2 mg) Group
n=15 Participants
Healthy volunteers receive buprenorphine (0.2 mg) during session (within-subjects design).
Buprenorphine 0.2 MG Sublingual Tablet: This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.2)
|
Buprenorphine (0.4 mg) Group
n=15 Participants
Healthy volunteers receive buprenorphine (0.4 mg) during session (within-subjects design).
Buprenorphine 0.4 MG Sublingual Tablet: This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.4)
|
Total
n=48 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
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
48 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
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: End of study - (Pre-administration of drug or placebo (Time 0), and approx 210 minutes after drug/placebo admin), End of study (210 min) shownThe Drug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", and "Want More". The "Feel Drug", "Feel High", "Like Drug", and "Want More" subscales are reported. All subscales are scored on a visual analogue scale (scroll bar on computer screen) ranging from 0 -100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
Outcome measures
| Measure |
Placebo Group
n=18 Participants
Healthy volunteers receive placebo
|
0.2 Buprenorphine
n=15 Participants
Healthy volunteers will receive 0.2 mg of buprenorphine
|
0.4 mg Buprenorphine
n=15 Participants
Healthy volunteers will receive 0.4 mg of buprenorphine
|
|---|---|---|---|
|
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine
Want More
|
4.27 units on a scale
Standard Deviation 1.3
|
12.47 units on a scale
Standard Deviation 1.9
|
21.57 units on a scale
Standard Deviation 1.96
|
|
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine
Feel Drug
|
13.57 units on a scale
Standard Deviation 2.1
|
36.57 units on a scale
Standard Deviation 4.5
|
59.89 units on a scale
Standard Deviation 1.55
|
|
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine
Like Drug
|
9.4 units on a scale
Standard Deviation 1.2
|
43.27 units on a scale
Standard Deviation 3.6
|
56.25 units on a scale
Standard Deviation 4.22
|
|
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Responses to Stress With and Without Buprenorphine
Feel High
|
6.0 units on a scale
Standard Deviation 1.5
|
27.27 units on a scale
Standard Deviation 2.5
|
41.69 units on a scale
Standard Deviation 3.45
|
Adverse Events
Placebo Group
0.2 Buprenorphine
0.4 mg Buprenorphine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place