Status:
COMPLETED
Desvenlafaxine in Opioid-Dependent Patients
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Pfizer
Conditions:
Depression
Opioid Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 condition...
Detailed Description
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 detaile...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02200406
Start Date
July 1 2014
End Date
January 1 2017
Last Update
October 23 2020
Active Locations (1)
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1
Centre de recherche du Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X0A9