NCT01873989

Testosterone Replacement for Male Opioid Agonist Maintained Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Pain
• Opioid Addiction
• Symptomatic Hypogonadism

Interventions

Type	Name	Description
DRUG	Testosterone replacement
OTHER	Waitlist control

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-06-10
• Last updated: 2017-06-12
• Results posted: 2017-06-12

Locations

1 site across 1 country: United States