Phase 2
N=15
Testosterone Replacement for Male Opioid Agonist Maintained Patients
Chronic Pain · Opioid Addiction · Symptomatic Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT01873989 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Number of Participants Demonstrating Abstinence — 5; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Testosterone replacement (Drug); Waitlist control (Other)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Yale University
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Demonstrating Abstinence |
5; 4 | — |
| PRIMARY Change in Pain Ratings |
1.8; 1.8 | — |
| PRIMARY Change in Sexual Dysfunction From Baseline to Week 8 |
6.95; -1 | — |
Summary
This study is designed to develop an effective treatment intervention for chronic pain, symptomatic hypogonadism, and opioid addiction
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01873989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.