Trial Outcomes & Findings for Effects of Buprenorphine on Mood in Adults With a Range of Depressive Symptomatology (NCT NCT02659787)

NCT ID: NCT02659787

Last Updated: 2019-05-29

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 38 participants
• Primary outcome timeframe: 0 through 3 hours after dosing.
• Results posted on: 2019-05-29

Participant Flow

Participant milestones

Measure	Placebo, Then Buprenorphine Participants first received placebo during first study session. After a washout period of 3 days, participants returned to lab and they then received 0.2 mg buprenorphine (Sublingual buprenorphine tablets (0.2mg).	Buprenorphine, Then Placebo Participants first received 0.2 mg buprenorphine (Sublingual buprenorphine tablets (0.2mg) during first study session. After a washout period of 3 days, participants returned to lab and they received placebo tablet.
First Intervention (1 Day) STARTED	19	19
First Intervention (1 Day) COMPLETED	19	19
First Intervention (1 Day) NOT COMPLETED	0	0
Washout (3 Days) STARTED	19	19
Washout (3 Days) COMPLETED	19	19
Washout (3 Days) NOT COMPLETED	0	0
Second Intervention (1 Day) STARTED	19	19
Second Intervention (1 Day) COMPLETED	19	19
Second Intervention (1 Day) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Buprenorphine on Mood in Adults With a Range of Depressive Symptomatology

Baseline characteristics by cohort

Measure	ALL Subjects n=38 Participants Subjects all receive placebo, 0.2 mg buprenorphine in crossover design
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 through 3 hours after dosing.

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.

Outcome measures

Measure	Low Dose Buprenorphine n=38 Participants Subjects all receive placebo, 0.2 mg buprenorphine in crossover design 0.2mg Buprenorphine: Sublingual buprenorphine tablets (0.2mg)	Placebo n=38 Participants Subjects all receive placebo, 0.2 mg buprenorphine in crossover design Placebo: Placebo
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Response With and Without Buprenorphine Feel Drug	21.03 units on a scale Standard Error 3.32	10.64 units on a scale Standard Error 2.42
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Response With and Without Buprenorphine Like Drug	23.09 units on a scale Standard Error 3.97	19.8 units on a scale Standard Error 4.12
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Response With and Without Buprenorphine Feel High	10.91 units on a scale Standard Error 2.44	5.74 units on a scale Standard Error 1.62
Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Subscales of the Drug Effects Questionnaire Subjective Response With and Without Buprenorphine Want More	17.46 units on a scale Standard Error 3.90	16.76 units on a scale Standard Error 3.86

Adverse Events

Buprenorphine, Then Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo, Then Buprenorphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Harriet de Wit

University of Chicago

Phone: 7737023560

Email: dewitlab@yoda.bsd.uchicago.edu

Results disclosure agreements

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