New Haven, Connecticut 06519

  • Symptomatic Hypogonadism

Purpose:

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


Study summary:

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).


Criteria:

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


NCT ID:

NCT01873989


Primary Contact:

Study Director
Christopher J Cutter, Ph.D.
Yale University

Declan T Barry, Ph.D.
Phone: 203-285-2708
Email: declan.barry@yale.edu


Backup Contact:

Email: richard.schottenfeld@yale.edu
Richard Schottenfeld, M.D.
Phone: 203-974-7349


Location Contact:

New Haven, Connecticut 06519
United States

Christopher J Cutter, Ph.D.
Phone: 203-285-2717
Email: christopher.cutter@yale.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

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