Skip to main content
OpenTrials
Completed

NCT Number: NCT01873989

Testosterone Replacement for Male Opioid Agonist Maintained Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid Addiction Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders Symptomatic Hypogonadism

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

MRU, APT Foundation, Inc

New Haven, Connecticut, 06519, United States

About this study

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:

  • To estimate, in male opioid agonist maintained patients, the prevalence of (a)symptomatic hypogonadism and (b) co-occurring symptomatic hypogonadism and chronic pain.
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone replacement

Drug

Waitlist Control

Other

Primary outcomes

  1. Number of Participants Demonstrating Abstinence

    Time frame: 8 weeks

    Number of participants who provided four consecutive weekly urines that were negative for illicit opioids in weeks 5 through 8.

  2. Change in Pain Ratings

    Time frame: 8 weeks

    Pain ratings will be assessed by self-report (4 items from Brief Pain Inventory). Change in pain ratings was assessed by examining the differences between pain ratings at baseline and week 8. Higher values are considered to be a worse outcome. The scale range is 0-10.

  3. Change in Sexual Dysfunction From Baseline to Week 8

    Time frame: 8 weeks

    Decreased sexual dysfunction will be assessed using the Erectile Function (EF) subscale of the International Index of Erectile Function (IIEF). The EF subscale has 6 items scored on a zero to five Likert-type scale. Change in sexual dysfunction was calculated by subtracting the mean EF subscale score at week 8 from the mean EF subscale score at baseline. The range of the EF subscale is 0-30 (with higher scores representing greater functioning). The Cut-offs for the EF subscales are as follows: no erectile dysfunction (score 26-30), mild erectile dysfunction (22-25), mild to moderate erectile dysfunction(17-21), moderate erectile dysfunction (11-16), and severe erectile dysfunction (0-10).

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2013
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.