Chronic PainPhase 1/2NCT01873989

Testosterone Replacement for Male Opioid Agonist Maintained Patients

A Phase 1/2 study testing Testosterone replacement in people with Chronic Pain and Opioid Addiction, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is designed to develop an effective treatment intervention for chronic pain, symptomatic hypogonadism, and opioid addiction Read more about this study

Who is it for?: Ages 18 to 50 years, men only
Conditions the study is for: Chronic Pain, Opioid Addiction, Symptomatic Hypogonadism
What is being tested?: Testosterone replacement
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Apr 2012to Jan 2015
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

Current suicide or homicide risk
Life-threatening or unstable medical condition
Known or suspected prostate or chest cancer or history of polycythemia

Trial locations and contacts

1 site in 1 country.

United States1 site

MRU, APT Foundation, Inc
New Haven, Connecticut, 06519

Other trials in United States

About this study

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

Read the 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).

Conditions: Chronic Pain, Opioid Addiction, Symptomatic Hypogonadism
Being tested: Testosterone replacement, Waitlist control
Keywords: Chronic pain, Opioid addiction, Symptomatic hypogonadism, Testosterone replacement, Opioid agonist maintenance, Methadone, Buprenorphine
Medical subject headings: Chronic Pain, Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Testosterone replacementDrug
Waitlist controlOther

Study groups in NCT01873989
Study group	Role	What they receive
Testosterone replacement	Experimental	Testosterone replacement for hypogonadism. Receives: Drug: Testosterone replacement
Waitlist control	Other	This arm involves watchful waiting. Receives: Other: Waitlist control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks
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.
Measured: 8 weeks
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).
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Jan 2015

First posted10 Jun 2013 (estimated)
Study startApr 2012
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01873989
Sponsor's protocol ID: 1105008492
Status last verified: Jun 2017
First submitted: 22 May 2013
Last updated: 12 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testosterone Replacement for Male Opioid Agonist Maintained Patients
ClinicalTrials.gov ID: NCT01873989
Acronym / sponsor ID: 1105008492
Conditions: Chronic Pain, Opioid Addiction, Symptomatic Hypogonadism
Keywords: Chronic pain, Opioid addiction, Symptomatic hypogonadism, Testosterone replacement, Opioid agonist maintenance, Methadone, Buprenorphine
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Study start: Apr 2012
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 10 Jun 2013 (estimated)
Results: Posted 12 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Testosterone replacement	Experimental	Drug: Testosterone replacementTestosterone replacement for hypogonadism.
Waitlist control	Other	Other: Waitlist controlThis arm involves watchful waiting.

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

Current suicide or homicide risk
Life-threatening or unstable medical condition
Known or suspected prostate or chest cancer or history of polycythemia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Testosterone replacement	Drug	Testosterone replacement
Waitlist control	Other	Waitlist control

Primary outcome

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.
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.
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).

Results and safety

Results posted to the registry on 12 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Testosterone Replacement	8	7
Waitlist Control	7	6

Primary outcome: Number of Participants Demonstrating Abstinence

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	Testosterone Replacement n = 8	Waitlist Control n = 7
Value	5	4

Primary outcome: Change in Pain Ratings

Time frame: 8 weeks. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Testosterone Replacement n = 8	Waitlist Control n = 7
Value	1.8 (.9 to 2.5)	1.8 (1 to 2.6)

Primary outcome: Change in Sexual Dysfunction From Baseline to Week 8

Time frame: 8 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Testosterone Replacement n = 8	Waitlist Control n = 7
Value	6.95 (1.4)	-1 (1.3)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Testosterone Replacement	0 of 8 (0%)	1 of 8 (12.5%)	Not reported
Waitlist Control	0 of 7 (0%)	1 of 7 (14.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher J Cutter, Ph.D. study director

Yale University

Declan T Barry, Ph.D. principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Testosterone replacement in people with Chronic Pain and Opioid Addiction, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Demonstrating Abstinence (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01873989.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.