Conditions: Chronic Pain Opioid Addiction Symptomatic Hypogonadism
Keywords: Chronic pain Opioid addiction Symptomatic hypogonadism Testosterone replacement Opioid agonist maintenance Methadone Buprenorphine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

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).

Arms:
arm 1: Testosterone replacement for hypogonadism. arm 2: This arm involves watchful waiting.

Interventions: intervention 1: Testosterone replacement intervention 2: Waitlist control
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: