Testosterone Replacement for Male Opioid Agonist Maintained Patients
|ClinicalTrials.gov Identifier: NCT01873989|
Recruitment Status : Completed
First Posted : June 10, 2013
Results First Posted : June 12, 2017
Last Update Posted : June 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain Opioid Addiction Symptomatic Hypogonadism||Drug: Testosterone replacement Other: Waitlist control||Phase 1 Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Testosterone Replacement for Male Opioid Agonist Maintained Patients|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Testosterone replacement
Testosterone replacement for hypogonadism.
Drug: Testosterone replacement
This arm involves watchful waiting.
Other: Waitlist control
- 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.
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873989
|United States, Connecticut|
|MRU, APT Foundation, Inc|
|New Haven, Connecticut, United States, 06519|
|Study Director:||Christopher J Cutter, Ph.D.||Yale University|
|Principal Investigator:||Declan T Barry, Ph.D.||Yale University|