Testosterone Replacement for Male Opioid Agonist Maintained Patients
Status: | Completed |
---|---|
Conditions: | Chronic Pain, Chronic Pain, Psychiatric, Endocrine |
Therapuetic Areas: | Endocrinology, Musculoskeletal, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 4/2/2016 |
Start Date: | April 2012 |
End Date: | September 2014 |
Contact: | Declan T Barry, Ph.D. |
Email: | declan.barry@yale.edu |
Phone: | 203-285-2708 |
This study is designed to develop an effective treatment intervention for chronic pain,
symptomatic hypogonadism, and opioid addiction
symptomatic hypogonadism, and opioid addiction
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 POD and symptomatic hypogonadism treated with opioid agonist
maintenance treatment (N=40).
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 POD and symptomatic hypogonadism treated with opioid agonist
maintenance treatment (N=40).
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
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