NCT01873989

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 chronic-pain

Timeline
Completed

Started Apr 2012

Longer than P75 for phase_1 chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

June 12, 2017

Completed
Last Updated

June 12, 2017

Status Verified

June 1, 2017

Enrollment Period

2.8 years

First QC Date

May 22, 2013

Results QC Date

December 6, 2016

Last Update Submit

June 8, 2017

Conditions

Chronic PainOpioid AddictionSymptomatic Hypogonadism

Keywords

Chronic painOpioid addictionSymptomatic hypogonadismTestosterone replacementOpioid agonist maintenanceMethadoneBuprenorphine

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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).

    8 weeks

Study Arms (2)

Testosterone replacement

EXPERIMENTAL

Testosterone replacement for hypogonadism.

Drug: Testosterone replacement

Waitlist control

OTHER

This arm involves watchful waiting.

Other: Waitlist control

Interventions

Testosterone replacementDRUG
Testosterone replacement
Waitlist controlOTHER
Waitlist control

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRU, APT Foundation, Inc

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Chronic PainOpioid-Related Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Declan Barry
Organization
Yale University
declan.barry@yale.edu
203-285-2708

Study Officials

  • Christopher J Cutter, Ph.D.

    Yale University

    STUDY DIRECTOR

  • Declan T Barry, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2013

First Posted

June 10, 2013

Study Start

April 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 12, 2017

Results First Posted

June 12, 2017

Record last verified: 2017-06

Locations

US(1)