Status:

COMPLETED

Testosterone Replacement for Male Opioid Agonist Maintained Patients

Lead Sponsor:

Yale University

Conditions:

Chronic Pain

Opioid Addiction

Eligibility:

MALE

18-50 years

Phase:

PHASE1

PHASE2

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 esti...

Eligibility Criteria

Inclusion

  • 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

  • Current suicide or homicide risk
  • Life-threatening or unstable medical condition
  • Known or suspected prostate or chest cancer or history of polycythemia

Key Trial Info

Start Date :

April 1 2012

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2015

Estimated Enrollment :

15 Patients enrolled

Trial Details

Trial ID

NCT01873989

Start Date

April 1 2012

End Date

January 1 2015

Last Update

June 12 2017

Active Locations (1)

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1

MRU, APT Foundation, Inc

New Haven, Connecticut, United States, 06519