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Testosterone Replacement for Male Opioid Agonist Maintained Patients

Primary Purpose

Chronic Pain, Opioid Addiction, Symptomatic Hypogonadism

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Testosterone replacement
Waitlist control
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, Opioid addiction, Symptomatic hypogonadism, Testosterone replacement, Opioid agonist maintenance, Methadone, Buprenorphine

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • MRU, APT Foundation, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Testosterone replacement

Waitlist control

Arm Description

Testosterone replacement for hypogonadism.

This arm involves watchful waiting.

Outcomes

Primary Outcome Measures

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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
May 22, 2013
Last Updated
June 8, 2017
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT01873989
Brief Title
Testosterone Replacement for Male Opioid Agonist Maintained Patients
Official Title
Testosterone Replacement for Male Opioid Agonist Maintained Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to develop an effective treatment intervention for chronic pain, symptomatic hypogonadism, and opioid addiction
Detailed 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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid Addiction, Symptomatic Hypogonadism
Keywords
Chronic pain, Opioid addiction, Symptomatic hypogonadism, Testosterone replacement, Opioid agonist maintenance, Methadone, Buprenorphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Testosterone replacement
Arm Type
Experimental
Arm Description
Testosterone replacement for hypogonadism.
Arm Title
Waitlist control
Arm Type
Other
Arm Description
This arm involves watchful waiting.
Intervention Type
Drug
Intervention Name(s)
Testosterone replacement
Intervention Type
Other
Intervention Name(s)
Waitlist control
Primary Outcome Measure Information:
Title
Number of Participants Demonstrating Abstinence
Description
Number of participants who provided four consecutive weekly urines that were negative for illicit opioids in weeks 5 through 8.
Time Frame
8 weeks
Title
Change in Pain Ratings
Description
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.
Time Frame
8 weeks
Title
Change in Sexual Dysfunction From Baseline to Week 8
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher J Cutter, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Declan T Barry, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MRU, APT Foundation, Inc
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Testosterone Replacement for Male Opioid Agonist Maintained Patients

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