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

NCT02659787 | Completed Results

• 1 other identifier: 14-0170
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (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

  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.

  0 through 3 hours after dosing.

Study Arms (2)

Low dose buprenorphine

ACTIVE COMPARATOR

Subjects all receive placebo, 0.2 mg buprenorphine in crossover design

Drug: 0.2mg Buprenorphine

Placebo

PLACEBO COMPARATOR

Subjects all receive placebo, 0.2 mg buprenorphine in crossover design

Drug: Placebo

Interventions

0.2mg Buprenorphine DRUG

Sublingual buprenorphine tablets (0.2mg)

Low dose buprenorphine

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult volunteers
• High school education
• Fluency in English
• BMI between 19 and 30

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (8)

• Falcon E, Maier K, Robinson SA, Hill-Smith TE, Lucki I. Effects of buprenorphine on behavioral tests for antidepressant and anxiolytic drugs in mice. Psychopharmacology (Berl). 2015 Mar;232(5):907-15. doi: 10.1007/s00213-014-3723-y. Epub 2014 Sep 3.

  PMID: 25178815 BACKGROUND

• Sullivan MD, Edlund MJ, Steffick D, Unutzer J. Regular use of prescribed opioids: association with common psychiatric disorders. Pain. 2005 Dec 15;119(1-3):95-103. doi: 10.1016/j.pain.2005.09.020. Epub 2005 Nov 17.

  PMID: 16298066 BACKGROUND

• Karp JF, Butters MA, Begley AE, Miller MD, Lenze EJ, Blumberger DM, Mulsant BH, Reynolds CF 3rd. Safety, tolerability, and clinical effect of low-dose buprenorphine for treatment-resistant depression in midlife and older adults. J Clin Psychiatry. 2014 Aug;75(8):e785-93. doi: 10.4088/JCP.13m08725.

  PMID: 25191915 BACKGROUND

• Nyhuis PW, Gastpar M, Scherbaum N. Opiate treatment in depression refractory to antidepressants and electroconvulsive therapy. J Clin Psychopharmacol. 2008 Oct;28(5):593-5. doi: 10.1097/JCP.0b013e31818638a4. No abstract available.

  PMID: 18794671 BACKGROUND

• Bodkin JA, Zornberg GL, Lukas SE, Cole JO. Buprenorphine treatment of refractory depression. J Clin Psychopharmacol. 1995 Feb;15(1):49-57. doi: 10.1097/00004714-199502000-00008.

  PMID: 7714228 BACKGROUND

• Striebel JM, Kalapatapu RK. The anti-suicidal potential of buprenorphine: a case report. Int J Psychiatry Med. 2014;47(2):169-74. doi: 10.2190/PM.47.2.g.

  PMID: 25084802 BACKGROUND

• Licht CM, de Geus EJ, Zitman FG, Hoogendijk WJ, van Dyck R, Penninx BW. Association between major depressive disorder and heart rate variability in the Netherlands Study of Depression and Anxiety (NESDA). Arch Gen Psychiatry. 2008 Dec;65(12):1358-67. doi: 10.1001/archpsyc.65.12.1358.

  PMID: 19047522 BACKGROUND

• Ipser JC, Terburg D, Syal S, Phillips N, Solms M, Panksepp J, Malcolm-Smith S, Thomas K, Stein DJ, van Honk J. Reduced fear-recognition sensitivity following acute buprenorphine administration in healthy volunteers. Psychoneuroendocrinology. 2013 Jan;38(1):166-70. doi: 10.1016/j.psyneuen.2012.05.002. Epub 2012 May 30.

  PMID: 22651957 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Harriet de Wit
• Organization: University of Chicago

dewitlab@yoda.bsd.uchicago.edu

7737023560

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 20, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 29, 2019
• Results First Posted: May 29, 2019

Record last verified: 2019-04

Locations

US (1)