Desvenlafaxine in Opioid-Dependent Patients
Information source: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression; Opioid Dependence
Intervention: Desvenlafaxine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Didier Jutras-Aswad Official(s) and/or principal investigator(s): Didier Jutras-Aswad, M.D., M.Sc., Principal Investigator, Affiliation: Centre Hospitalier de l'Université de Montréal Suzanne Brissette, M.D., M.Sc., Study Chair, Affiliation: Centre Hospitalier de l'Université de Montréal Julie Bruneau, M.D., M.Sc., Study Chair, Affiliation: Centre Hospitalier de l'Université de Montréal Paul Lespérance, M.D., M.Sc., Study Chair, Affiliation: Centre Hospitalier de l'Université de Montréal Clairélaine Ouellet-Plamondon, M.D., Study Chair, Affiliation: Centre Hospitalier de l'Université de Montréal
Overall contact: Christophe Fadainia, Phone: 514-890-8000, Ext: 36153, Email: christophe.fadainia.chum@ssss.gouv.qc.ca
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.
Clinical Details
Official title: An Open-Label Pilot Study of Desvenlafaxine for Opioid-Dependent Patients With Comorbid Depression
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Tolerability: Systematic Assessment for Treatment Emergent Events (SAFTEE)
Secondary outcome: effect of Desvenlafaxine on depressive symptomseffect of Desvenlafaxine on depressive symptoms Response to treatment Feasibility: Proportion of persons screened who are eligible and enrolled Treatment adherence Effect of Desvenlafaxine administration on QT/QTc interval prolongation Feasibility: Proportion of scheduled study visits completed and biological samples collected Potential for drug interactions between methadone and antidepressants - Effect of Desvenlafaxine on methadone serum level (pharmacokinetic variability) Methadone dose adjustments
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Christophe Fadainia, Phone: 514-890-8000, Ext: 36153, Email: christophe.fadainia.chum@ssss.gouv.qc.ca
Centre de recherche du Centre Hospitalier de l'Université de Montréal, Montréal, Quebec H2X0A9, Canada; Recruiting Christophe Fadainia, Phone: 514-890-8000, Ext: 36153, Email: christophe.fadainia.chum@ssss.gouv.qc.ca Didier Jutras-Aswad, M.D., M.Sc., Principal Investigator
Additional Information
Starting date: July 2014
Last updated: February 10, 2015
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