Testosterone Replacement for Male Opioid Agonist Maintained Patients

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01873989
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 33
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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).

Study Design

• Study Type: Interventional
• 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: Apr 1, 2012
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants Demonstrating Abstinence [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 [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 [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MRU, APT Foundation, Inc	New Haven	Connecticut	United States	06519

Sponsors and Collaborators

• Yale University

Investigators

• Study Director: Christopher J Cutter, Ph.D., Yale University
• Principal Investigator: Declan T Barry, Ph.D., Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01873989
• Other Study ID Numbers: 1105008492
• First Posted: Jun 10, 2013
• Last Update Posted: Jun 12, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by Yale University: Chronic pain; Opioid addiction; Symptomatic hypogonadism; Testosterone replacement; Opioid agonist maintenance; Methadone; Buprenorphine
• Additional relevant MeSH terms: Hypogonadism; Chronic Pain; Opioid-Related Disorders; Behavior, Addictive; Testosterone

Study Results

Participant Flow

Arm/Group Title	Testosterone Replacement	Waitlist Control
Arm/Group Description	Testosterone replacement for hypogonadism. Testosterone replacement	This arm involves watchful waiting. Waitlist control
Period Title: Overall Study
STARTED	8	7
COMPLETED	7	6
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Testosterone Replacement	Waitlist Control	Total
Arm/Group Description	Testosterone replacement for hypogonadism. Testosterone replacement	This arm involves watchful waiting. Waitlist control	Total of all reporting groups
Overall Participants	8	7	15
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 100%	7 100%	15 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (10)	48 (11)	47 (10)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	8 100%	7 100%	15 100%
Region of Enrollment (participants) [Number]
United States	8 100%	7 100%	15 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Testosterone Replacement	Waitlist Control
Arm/Group Description	Testosterone replacement for hypogonadism. Testosterone replacement	This arm involves watchful waiting. Waitlist control
Measure Participants	8	7
Count of Participants [Participants]	5 62.5%	4 57.1%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Testosterone Replacement	Waitlist Control
Arm/Group Description	Testosterone replacement for hypogonadism. Testosterone replacement	This arm involves watchful waiting. Waitlist control
Measure Participants	8	7
Mean (95% Confidence Interval) [units on a scale]	1.8	1.8

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Testosterone Replacement	Waitlist Control
Arm/Group Description	Testosterone replacement for hypogonadism. Testosterone replacement	This arm involves watchful waiting. Waitlist control
Measure Participants	8	7
Mean (Standard Deviation) [units on a scale]	6.95 (1.4)	-1 (1.3)

Adverse Events

Arm/Group Title	Testosterone Replacement		Waitlist Control
Arm/Group Description	Testosterone replacement for hypogonadism. Testosterone replacement		This arm involves watchful waiting. Waitlist control
All Cause Mortality
	Testosterone Replacement		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Testosterone Replacement		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Testosterone Replacement		Waitlist Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/8 (12.5%)		1/7 (14.3%)
Musculoskeletal and connective tissue disorders
Fatigue	1/8 (12.5%)	1	1/7 (14.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.