Chronic Pain Clinical Trial
Official title:
Testosterone Replacement for Male Opioid Agonist Maintained Patients
Verified date | June 2017 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed to develop an effective treatment intervention for chronic pain, symptomatic hypogonadism, and opioid addiction
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 |
Country | Name | City | State |
---|---|---|---|
United States | MRU, APT Foundation, Inc | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University |
United States,
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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