Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Pfizer Reference Award Number | Other Grant/Funding Number | WI187002 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desvenlafaxine | Other |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desvenlafaxine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability: Systematic Assessment for Treatment Emergent Events (SAFTEE) | Safety and adverse effects with the Systematic Assessment for Treatment Emergent Events (SAFTEE) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| effect of Desvenlafaxine on depressive symptoms | Responders will be determined by a 50% reduction in (Hamilton Depression Rating Scale) HAM-D scores, and remitters will be determined based on scores of ≤7. | 8 weeks |
| effect of Desvenlafaxine on depressive symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Substance use | number of days of substance use as assessed with The Time Line Follow-Back (TFLB), urine-drug testing and alcohol-breathalyzer testing. | 8 weeks |
| Effect of Desvenlafaxine on anxiety | Change from Baseline in anxiety and mood. It will be assessed with the Hamilton Anxiety Rating Scale (HAM-A) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Didier Jutras-Aswad, M.D., M.Sc. | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| 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) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de recherche du Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X0A9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29738425 | Derived | El Hage C, Ghabrash MF, Dubreucq S, Brissette S, Lesperance F, Lesperance 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D009293 | Opioid-Related Disorders |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069468 | Desvenlafaxine Succinate |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
Responders will be determined by a 50% reduction in the Montgomery-Asberg Depression Scale (MADRS) scores, and remitters will be determined based on scores of 10. |
| 8 weeks |
| Response to treatment | A favorable response will be defined as a score of 1 or 2 (very much or much improved) on the Clinical Global Impression CGI-I subscale | 8 weeks |
| Feasibility: Proportion of persons screened who are eligible and enrolled | Proportion of persons screened who are eligible and enrolled | Baseline |
| Treatment adherence | Compliance will be evaluated at each in-person follow-up visit. Treatment adherence will be calculated as the total number of tablets dispensed minus the number returned, divided by the total number of tablets dispensed | 8 weeks |
| Effect of Desvenlafaxine administration on QT/QTc interval prolongation | It will be assessed by electrocardiograms (upper limit for safety should be 500ms). | 4 weeks |
| Feasibility: Proportion of scheduled study visits completed and biological samples collected | Proportion of scheduled study visits completed and biological samples collected | 8 weeks |
| Potential for drug interactions between methadone and antidepressants - Effect of Desvenlafaxine on methadone serum level (pharmacokinetic variability) | Change from baseline in methadone serum level. We will assessed the methadone serum level at baseline and after a month of treatment. | 4 weeks |
| Methadone dose adjustments | Change from baseline in methadone dose. Each dose adjustment occurring during the trial will be noted at each follow-up visit | 2 - 4 weeks |
| 8 weeks |
| Effect of Desvenlafaxine on blood pressure and heart rate | Change from Baseline in Systolic Blood Pressure and heart rate | 8 weeks |
| Effect of Desvenlafaxine on opioid craving | Assessed with the abbreviated Heroin Craving Questionnaire (HCQ) - Change from Baseline in Craving. | 8 weeks |
| Effect of Desvenlafaxine on quality of life | Change from baseline in Quality of life. It will be assessed with the World Health Organization Quality of Life questionnaire (WHOQOL-BREF) | 8 weeks |
| Effect of Desvenlafaxine on disability | Change from baseline in disability. It will be assessed with the Sheehan Disability Scale (SDS) | 8 weeks |
| Effect of Desvenlafaxine on suicidal behaviour | Change from Baseline in suicidal behaviour. It will be assessed with the Columbia-Suicide Severity Rating Scale (CSSRS) | 8 weeks |
| Effect of Desvenlafaxine on testosterone level | Change from Baseline in testosterone. | 4 weeks |
| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |