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Desvenlafaxine in Opioid-Dependent Patients

NCT02200406 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-10-23

No results posted yet for this study

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.

Conditions

  • Depression
  • Opioid Dependence
  • Methadone Treatment

Interventions

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Didier Jutras-Aswad, M.D., M.Sc. · Centre hospitalier de l'Université de Montréal (CHUM)

  • Suzanne Brissette, M.D., M.Sc. · Centre hospitalier de l'Université de Montréal (CHUM)

  • Julie Bruneau, M.D., M.Sc. · Centre hospitalier de l'Université de Montréal (CHUM)

  • Paul Lespérance, M.D., M.Sc. · Centre hospitalier de l'Université de Montréal (CHUM)

  • Clairélaine Ouellet-Plamondon, M.D. · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02200406 on ClinicalTrials.gov