A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain

Study Overview
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Brief Summary
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This will be a single-blind, placebo-run-in trial. Subjects will be informed that they may receive Venlafaxine or placebo during the course of the trial. All subjects will, in fact, receive placebo for the first two weeks. All subjects will then be placed on 150-225 mg per day of venlafaxine. Primary outcome assessment will compare pain intensity at 2 weeks (after placebo) to that at 12 weeks (after 10 weeks of Venlafaxine treatment). Study Hypothesis: In subjects who continue to have activity-limiting osteoarthritis pain after treatment with acetaminophen or non-steroidal anti-inflammatory agents, 150-225 mg Venlafaxine per day over 10 weeks will provide significant additional pain relief over that achieved with placebo (more than 30% reduction after Venlafaxine treatment).

Official Title
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A Single-Blind Placebo Run-In Study of Venlafaxine for Activity-Limiting Osteoarthritis Pain

Conditions
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Osteoarthritis, Pain

Intervention / Treatment
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* Drug: Venlafaxine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 - 80 years Physician diagnosis of OA in hip, knee or spine Significant activity limitation due to pain for at least one month on the Western Ontario and McMasters University Osteoarthritis Index (WOMAC) and average pain more than 5/10 on Brief Pain Inventory despite adequate treatment with acetaminophen or NSAIDs (This will identify an OA group with significant psychological distress and a desire for treatment). Depression status is not restricted, but will be monitored with PRIME-MD interview and the SCL-20. We anticipate depressive symptoms will be common in this population due to the above requirement for activity limitation. Exclusion Criteria: Cannot read and write English Significant cognitive impairment History of psychosis or mania Current suicidal ideation Current substance abuse or dependence Current use of opioids or any antidepressant medication Use of investigational drug within the past month

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>All subjects receive placebo for the first two weeks and then Venlafaxine for the next 10 weeks, but they are blind to what they are receiving | Drug: Venlafaxine<br>* Weeks 0-2: placebo. Weeks 2-3: 75 mg Venlafaxine. Weeks 3-4: 150 mg Venlafaxine. Weeks 4-12: 150-225 mg Venlafaxine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in average pain intensity on Brief Pain Inventory |  | Between 2 weeks and 12 weeks | 
| Difference in pain intensity on Western Ontario McMasters University Osteoarthritis Index (WOMAC) |  | Between 2 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in pain interference on Western Ontario McMasters University Osteoarthritis Index (WOMAC) |  | Between 2 and 12 weeks | 
| Difference in role function as assessed by the Sheehan Disability Scale |  | Between 2 and 12 weeks | 
| Difference in observed physical function as assessed by the Aggravated Locomotor Function Score |  | Between 2 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis pain, activity limitation, antidepressant, depression, single-blind