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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01873989
Other study ID # 1105008492
Secondary ID
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
Health authority
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

Study Design


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
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