Testosterone Replacement for Male Opioid Agonist Maintained Patients

Chronic Pain Clinical Trial

Official title:

Testosterone Replacement for Male Opioid Agonist Maintained Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873989
• Other study ID #: 1105008492
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 22, 2013
• Last updated: June 8, 2017
• Start date: April 2012
• Est. completion date: January 2015

Study information

• Verified date: June 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Chronic Pain
• Hypogonadism
• Opioid Addiction
• Symptomatic Hypogonadism

Intervention

Drug:
• Testosterone replacement

Other:
• Waitlist control

Locations

Country	Name	City	State
United States	MRU, APT Foundation, Inc	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Demonstrating Abstinence	Number of participants who provided four consecutive weekly urines that were negative for illicit opioids in weeks 5 through 8.	8 weeks
Primary	Change in Pain Ratings	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.	8 weeks
Primary	Change in Sexual Dysfunction From Baseline to Week 8	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).	8 weeks