Testosterone Replacement for Male Opioid Agonist Maintained Patients

Phase 1

Completed

• Conditions: Symptomatic Hypogonadism; Chronic Pain; Opioid Addiction
• Interventions: Drug: Testosterone replacement; Other: Waitlist control

• Registration Number: NCT01873989
• Lead Sponsor: Yale University

Brief Summary

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

Detailed Description

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:

1. To estimate, in male opioid agonist maintained patients, the prevalence of (a)symptomatic hypogonadism and (b) co-occurring symptomatic hypogonadism and chronic pain.

2. 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).

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-05-22
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-10
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2016-12-06
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-08
• Last Update Submitted: 2017-06-08
• Results First Posted: 2017-06-12
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

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Exclusion Criteria

• Current suicide or homicide risk
• Life-threatening or unstable medical condition
• Known or suspected prostate or chest cancer or history of polycythemia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Testosterone replacement	Testosterone replacement	Testosterone replacement for hypogonadism.
Waitlist control	Waitlist control	This arm involves watchful waiting.

Primary Outcome Measures

Name	Time	Method
Change in Pain Ratings	8 weeks	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.
Change in Sexual Dysfunction From Baseline to Week 8	8 weeks	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).
Number of Participants Demonstrating Abstinence	8 weeks	Number of participants who provided four consecutive weekly urines that were negative for illicit opioids in weeks 5 through 8.

Trial Locations

Locations (1)

MRU, APT Foundation, Inc; 🇺🇸 New Haven, Connecticut, United States