Trial | NCT02200406  Report issue

Title

Desvenlafaxine in Opioid-Dependent Patients
An Open-Label Pilot Study of Desvenlafaxine for Opioid-Dependent Patients With Comorbid Depression

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    18
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.
To assess the feasibility, tolerability and acceptability of 8 weeks of Desvenlafaxine (DESV) administration among opioid-dependent subjects in a methadone-maintenance program, we will collect detailed information on compliance to DESV treatment, side effects, methadone plasma levels, methadone dose changes and QTc measures.

To explore the effects of DESV on depressive symptoms among opioid-dependent subjects on methadone-maintenance treatment. The severity and symptoms of depression will be evaluated by using the MADRS, the HRDS, and the CGI scale.

To explore the effects of DESV on substance use, anxiety, craving, quality of life and suicidal risk.
Study Started
Jul 31
2014
Primary Completion
Jan 31
2017
Study Completion
Jan 31
2017
Last Update
Oct 23
2020

Drug Desvenlafaxine

All subjects will receive 50 mg of the medication during week 1 and 2, then 50-100 mg (based on the psychiatrist judgment) for the following 6 weeks. Subjects who experience significant adverse reactions with the 100mg dose during weeks 2 to 4 could return to the lower dose of 50 mg if judged clinically appropriate by the study psychiatrist.

  • Other names: PRISTIQ

Desvenlafaxine Other

Open-label pilot study Desvenlafaxine will be administered during 56 consecutive days Desvenlafaxine will be administered in the morning at a 50 mg dose during weeks 1 and 2, and at 50-100 mg doses (based on the study psychiatrist's judgment) during the 6 following weeks.

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
No Results Posted