Testosterone Replacement for Male Opioid Agonist Maintained Patients

Yale University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Symptomatic Hypogonadism; Opioid Addiction; Chronic Pain

Treatments: Drug: Testosterone replacement; Other: Waitlist control

Study type: Interventional

Funder types: Other

Identifiers

NCT01873989

1105008492

Details and patient eligibility

About

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

Full 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).

Enrollment: 15 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Testosterone replacement

Experimental group

Description:

Testosterone replacement for hypogonadism.

Treatment:

Drug: Testosterone replacement

Waitlist control

Other group

Description:

This arm involves watchful waiting.

Treatment:

Other: Waitlist control