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Testosterone Replacement for Male Opioid Agonist Maintained Patients

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ClinicalTrials.gov Identifier: NCT01873989
Recruitment Status : Completed
First Posted : June 10, 2013
Results First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

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

Condition or disease Intervention/treatment Phase
Chronic Pain Opioid Addiction Symptomatic Hypogonadism Drug: Testosterone replacement Other: Waitlist control Phase 1 Phase 2

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:

  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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Testosterone replacement
Testosterone replacement for hypogonadism.
Drug: Testosterone replacement
Waitlist control
This arm involves watchful waiting.
Other: Waitlist control



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873989


Locations
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United States, Connecticut
MRU, APT Foundation, Inc
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
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Study Director: Christopher J Cutter, Ph.D. Yale University
Principal Investigator: Declan T Barry, Ph.D. Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01873989     History of Changes
Other Study ID Numbers: 1105008492
First Posted: June 10, 2013    Key Record Dates
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017
Last Verified: June 2017

Keywords provided by Yale University:
Chronic pain
Opioid addiction
Symptomatic hypogonadism
Testosterone replacement
Opioid agonist maintenance
Methadone
Buprenorphine

Additional relevant MeSH terms:
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Chronic Pain
Behavior, Addictive
Hypogonadism
Opioid-Related Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Compulsive Behavior
Impulsive Behavior
Gonadal Disorders
Endocrine System Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Methyltestosterone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal