Testosterone Replacement for Male Opioid Agonist Maintained Patients

Study Overview
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Brief Summary
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This study is designed to develop an effective treatment intervention for chronic pain, symptomatic hypogonadism, and opioid addiction

Detailed Description
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This study aims to assess the initial efficacy of testosterone replacement in male opioid agonist patients with symptomatic hypogonadism and chronic pain. The study has two specific aims: To estimate, in male opioid agonist maintained patients, the prevalence of (a)symptomatic hypogonadism and (b) co-occurring symptomatic hypogonadism and chronic pain. To conduct a pilot randomized clinical trial to obtain data regarding the feasibility, acceptability, and efficacy (compared to waitlist control) of testosterone replacement for male patients with chronic pain and opioid dependence, and symptomatic hypogonadism treated with opioid agonist maintenance treatment (N=40).

Official Title
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Testosterone Replacement for Male Opioid Agonist Maintained Patients

Conditions
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Chronic Pain, Opioid Addiction, Symptomatic Hypogonadism

Intervention / Treatment
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* Drug: Testosterone replacement
* Other: Waitlist control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 and 50 years of age Male buprenorphine- or methadone-maintained patients at the APT Foundation Moderate to severe chronic pain Meet criteria for symptomatic hypogonadism Understand English Interested in receiving testosterone replacement Exclusion Criteria: Current suicide or homicide risk Life-threatening or unstable medical condition Known or suspected prostate or chest cancer or history of polycythemia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosterone replacement<br>Testosterone replacement for hypogonadism. | Drug: Testosterone replacement<br> <br> |
| Other: Waitlist control<br>This arm involves watchful waiting. | Other: Waitlist control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Demonstrating Abstinence | Number of participants who provided four consecutive weekly urines that were negative for illicit opioids in weeks 5 through 8. | 8 weeks | 
| Change in Pain Ratings | Pain ratings will be assessed by self-report (4 items from Brief Pain Inventory). Change in pain ratings was assessed by examining the differences between pain ratings at baseline and week 8. Higher values are considered to be a worse outcome. The scale range is 0-10. | 8 weeks | 
| Change in Sexual Dysfunction From Baseline to Week 8 | Decreased sexual dysfunction will be assessed using the Erectile Function (EF) subscale of the International Index of Erectile Function (IIEF). The EF subscale has 6 items scored on a zero to five Likert-type scale. Change in sexual dysfunction was calculated by subtracting the mean EF subscale score at week 8 from the mean EF subscale score at baseline. The range of the EF subscale is 0-30 (with higher scores representing greater functioning). The Cut-offs for the EF subscales are as follows: no erectile dysfunction (score 26-30), mild erectile dysfunction (22-25), mild to moderate erectile dysfunction(17-21), moderate erectile dysfunction (11-16), and severe erectile dysfunction (0-10). | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methadone, Chronic pain, Opioid addiction, Symptomatic hypogonadism, Testosterone replacement, Opioid agonist maintenance, Buprenorphine