Desvenlafaxine in Opioid-Dependent Patients

NCT02200406

Last updated date
Study Location
Centre de recherche du Centre Hospitalier de l'Université de Montréal
Montréal, Quebec, H2X0A9, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Depression, Opioid Dependence, Methadone Treatment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Depression, Opioid Dependence, Methadone TreatmentDesvenlafaxine in Opioid-Dependent Patients
NCT02200406
  1. Montréal, Quebec
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Desvenlafaxine in Opioid-Dependent Patients
Official Title  ICMJE An Open-Label Pilot Study of Desvenlafaxine for Opioid-Dependent Patients With Comorbid Depression
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 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Opioid Dependence
  • Methadone Treatment
Intervention  ICMJE 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 Name: PRISTIQ
Study Arms  ICMJE Desvenlafaxine
  • 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.
Intervention: Drug: Desvenlafaxine
Publications * El Hage C, Ghabrash MF, Dubreucq S, Brissette S, Lespérance F, Lespérance P, Ouellet-Plamondon C, Bruneau J, Jutras-Aswad D. A pilot, open-label, 8-week study evaluating desvenlafaxine for treatment of major depression in methadone-maintained individuals with opioid use disorder. Int Clin Psychopharmacol. 2018 Sep;33(5):268-273. doi: 10.1097/YIC.0000000000000223.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2017)
18
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2014)
20
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02200406
Other Study ID Numbers  ICMJE WI187002
Pfizer Reference Award Number ( Other Grant/Funding Number: WI187002 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre hospitalier de l'Université de Montréal (CHUM)
Study Sponsor  ICMJE Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Didier Jutras-Aswad, M.D., M.Sc.Centre hospitalier de l'Université de Montréal (CHUM)
Study Chair:Suzanne Brissette, M.D., M.Sc.Centre hospitalier de l'Université de Montréal (CHUM)
Study Chair:Julie Bruneau, M.D., M.Sc.Centre hospitalier de l'Université de Montréal (CHUM)
Study Chair:Paul Lespérance, M.D., M.Sc.Centre hospitalier de l'Université de Montréal (CHUM)
Study Chair:Clairélaine Ouellet-Plamondon, M.D.Centre hospitalier de l'Université de Montréal (CHUM)
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP