Desvenlafaxine in Opioid-Dependent Patients

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Background: Although substitution therapy has been shown to be highly effective to retain opioid-dependent patients in treatment and reduce drug use, this population is afflicted by numerous conditions including depression. Unfortunately, studies published thus far have reported inconsistent or no difference in response between placebo therapy and antidepressants such as selective serotonin reuptake inhibitors. Objective: To assess the feasibility of Desvenlafaxine (DESV) administration among opioid-dependent subjects and explore its effect on depressive symptoms. Methods: Open-label pilot trial of 8 weeks of DESV 50-100 mg/day in 20 methadone-maintained individuals with comorbid depressive symptoms at the Centre hospitalier de l'Université de Montréal. Significance: This pilot study will lay down the foundation on which a larger multisite clinical trial could be conducted to examine DESV as new treatment for opioid-dependent population with comorbid depression.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM); Didier Jutras-Aswad
• Collaborators: Centre hospitalier de l'Université de Montréal (CHUM); Pfizer
• Treatments: Analgesics, Opioid; Desvenlafaxine Succinate

Criteria

Inclusion Criteria:

• DSM-IV-TR criteria for opioid dependence;

• Subject is on methadone treatment in the substitution program for at least 4 weeks;

• Subject is aged between 18 and 65 years old;

• subject meets the DSM-V TR criteria for major depressive episode, according to the study psychiatrist and confirmed by the Mini International Neuropsychiatric Interview (MINI);

• Subject reports a score of 20 or higher on the MADRS;

• Subject is eligible for and consents to the study;

• subject is able to give valid, informed consent;

• subject is able to speak and read French or English (grade-nine level of language required)

Exclusion Criteria:

• Unstable medical illness, defined as any medical illness which has not been well-controlled with standard-of-care medications;

• Severe psychiatric condition (e.g., current acute psychosis, past or current hypomania/mania) based on the MINI;

• Pregnancy or breastfeeding;

• Inability to use a medically acceptable form of contraception throughout the study duration. A medically acceptable form of contraception is either: (1) contraceptive pill or intrauterine device or depot hormonal preparation (ring, injection, implant); and/or (2) a barrier method of contraception such as diaphragm, sponge with spermicide or condom;

• Subject currently takes another antidepressant;

• Treatment with Desvenlafaxine at any time in the past;

• Known hypersensitivity to venlafaxine;

• Subject is undergoing psychotherapies for current depression (support therapy or counseling are allowed);

• Subject failed to respond to two or more Health-Canada-approved antidepressants during current episode;

• Unstable Axis-II personality disorder or other Axis-II disorder which has been the primary focus of treatment in the past 3 months, as ascertained by a study psychiatrists;

• Medical diagnosis of kidney and/or liver failure