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

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT02659787
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
10
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study seeks to to study the effects of buprenorphine, a partial mu-opioid agonist, on depressed mood in a healthy young adults with a range of depressive symptomatology.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.2mg Buprenorphine
  • Drug: Placebo
 N/A

Detailed Description

It has been shown that opioid analgesics, particularly the mu-opioid partial agonist buprenorphine, have anti-depressant properties in laboratory animal models. In humans, rates of prescription opioid abuse are significantly higher in patients with depression. This suggests that individuals with negative mood states (e.g., depressive states) may respond more positively to opioid drugs. A handful of small studies in in humans have suggested that buprenorphine reduces symptoms of depression in patients who did not respond to standard anti-depressants, and laboratory studies have shown buprenorphine may reduce responses to some types of negative stimuli and enhance responses to positive stimuli. However, a controlled laboratory study assessing potential anti-depressant effects of an opioid medication has never been conducted. In this project, the investigators propose to examine depressive symptomatology as a predictor of subjective mood responses to buprenorphine, using two measures; i) self-reported depressive symptomatology as measured by the Beck Depression Inventory (BDI-II), and ii) physiological indices of depressive symptomatology as measured by heart rate variability. Reduced heart rate variability has been shown to be associated with depression, and such a physiological measure may allow for the detection of more subtle effects than would a self-report questionnaire alone. Healthy volunteers (N=60) will first complete the BDI and provide baseline measures of heart rate variability. Then they will attend two laboratory sessions, at which they will receive placebo or 0.2mg buprenorphine. The investigators have tested these low doses of buprenorphine in previous studies, and they produce measurable changes in mood and behavior in healthy volunteers. The investigators will collect measures of mood and physiological drug response (pupillometry, heart rate, and blood pressure) at regular intervals throughout each session, and will then examine their baseline indices of depressive symptomatology in relation to responses to the drug. The central hypothesis is that individuals with greater self-reported depressive symptoms and lower heart rate variability will experience the greatest enhancement of mood in response to buprenorphine. It is expected that this work will provide a better understanding of which individuals are most likely to experience positive mood effects in response to opioid drugs, and may therefore be at-risk for developing an opioid use disorder. Furthermore, it may lay the foundation for future research in the development of novel opioid-based treatments for depression.

Design: The study will use a 3-session within-subjects double-blind design in which participants will receive single doses of buprenorphine (0, 0.2 mg sublingual) in randomized order. All screening, orientation, and study session procedures will take place in the Human Behavioral Pharmacology Laboratory suite in the L4 wing of 5841 S. Maryland Ave.

Drug and Doses: Investigators will administer placebo, 0.2 mg buprenorphine (Temgesic) via sublingual tablet in counterbalanced order under double-blind conditions. These tablets dissolve within 5-8 minutes. This drug has been approved for treatment of severe pain. The onset of action after sublingual administration is 30 minutes, with a peak plasma concentration at 1/5-2 hours and a half-life of 5 hours. The dose of buprenorphine are very low, and the average maintenance dose for opioid abusers is 8 mg. Doses will be separated by at least 72 hours.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Effects of Buprenorphine on Mood in Adults With a Range of Depressive Symptomatology
Study Start Date :
Jun 1, 2016
Actual Primary Completion Date :
Apr 1, 2017
Actual Study Completion Date :
Apr 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Low dose buprenorphine

Subjects all receive placebo, 0.2 mg buprenorphine in crossover design

Drug: 0.2mg Buprenorphine
Sublingual buprenorphine tablets (0.2mg)
Placebo Comparator: Placebo

Subjects all receive placebo, 0.2 mg buprenorphine in crossover design

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. 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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Healthy adult volunteers

  • High school education

  • Fluency in English

  • BMI between 19 and 30

Exclusion Criteria:

  • Medical conditions contraindicating study participation

  • Regularly medication use

  • Current or past opioid abuse or dependence

  • Current or past drug or alcohol dependence

  • Psychiatric illness

  • Women who are pregnant or nursing

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Chicago Chicago Illinois United States 60637

Sponsors and Collaborators

  • University of Chicago

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT02659787
Other Study ID Numbers:
  • 14-0170
First Posted:
Jan 20, 2016
Last Update Posted:
May 29, 2019
Last Verified:
Apr 1, 2019
Additional relevant MeSH terms:
Depression
Buprenorphine

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Placebo, Then Buprenorphine Buprenorphine, Then Placebo
Arm/Group Description 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). 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.
Period Title: First Intervention (1 Day)
STARTED 19 19
COMPLETED 19 19
NOT COMPLETED 0 0
Period Title: First Intervention (1 Day)
STARTED 19 19
COMPLETED 19 19
NOT COMPLETED 0 0
Period Title: First Intervention (1 Day)
STARTED 19 19
COMPLETED 19 19
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title ALL Subjects
Arm/Group Description Subjects all receive placebo, 0.2 mg buprenorphine in crossover design
Overall Participants 38
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
38
100%
>=65 years
0
0%
Sex: Female, Male (Count of Participants)
Female
23
60.5%
Male
15
39.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
2
5.3%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
9
23.7%
White
20
52.6%
More than one race
0
0%
Unknown or Not Reported
7
18.4%

Outcome Measures

1. Primary Outcome
Title 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
Description 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.
Time Frame 0 through 3 hours after dosing.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Buprenorphine Placebo
Arm/Group Description Subjects all receive placebo, 0.2 mg buprenorphine in crossover design 0.2mg Buprenorphine: Sublingual buprenorphine tablets (0.2mg) Subjects all receive placebo, 0.2 mg buprenorphine in crossover design Placebo: Placebo
Measure Participants 38 38
Feel Drug
21.03
(3.32)
10.64
(2.42)
Like Drug
23.09
(3.97)
19.8
(4.12)
Feel High
10.91
(2.44)
5.74
(1.62)
Want More
17.46
(3.90)
16.76
(3.86)

Adverse Events

Time Frame 6 days for each intervention
Adverse Event Reporting Description
Arm/Group Title Placebo, Then Buprenorphine Buprenorphine, Then Placebo
Arm/Group Description 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 (0.2 mg). Participants first received 0.2 mg buprenorphine (Sublingual buprenorphine tablets (0.2 mg)) during first study session. After a washout period of 3 days, participants returned to lab and they then received placebo tablet.
All Cause Mortality
Placebo, Then Buprenorphine Buprenorphine, Then Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/19 (0%) 0/19 (0%)
Serious Adverse Events
Placebo, Then Buprenorphine Buprenorphine, Then Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/19 (0%) 0/19 (0%)
Other (Not Including Serious) Adverse Events
Placebo, Then Buprenorphine Buprenorphine, Then Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/19 (0%) 0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Harriet de Wit
Organization University of Chicago
Phone 7737023560
Email dewitlab@yoda.bsd.uchicago.edu
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT02659787
Other Study ID Numbers:
  • 14-0170
First Posted:
Jan 20, 2016
Last Update Posted:
May 29, 2019
Last Verified:
Apr 1, 2019