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This study is designed to develop an effective treatment intervention for chronic pain, symptomatic hypogonadism, and opioid addiction
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testosterone replacement | Experimental | Testosterone replacement for hypogonadism. |
|
| Waitlist control | Other | This arm involves watchful waiting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone replacement | Drug |
| ||
| Waitlist control |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J Cutter, Ph.D. | Yale University | Study Director |
| Declan T Barry, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MRU, APT Foundation, Inc | New Haven | Connecticut | 06519 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Testosterone Replacement | Testosterone replacement for hypogonadism. Testosterone replacement |
| FG001 | Waitlist Control | This arm involves watchful waiting. Waitlist control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Testosterone Replacement | Testosterone replacement for hypogonadism. Testosterone replacement |
| BG001 | Waitlist Control | This arm involves watchful waiting. Waitlist control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 8 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Testosterone Replacement | Testosterone replacement for hypogonadism. Testosterone replacement |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | patient reported general fatigue |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Declan Barry | Yale University | 203-285-2708 | declan.barry@yale.edu |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 8 weeks |
|
|
|
| Primary | 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). | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| 0 |
| 8 |
| 1 |
| 8 |
| EG001 | Waitlist Control | This arm involves watchful waiting. Waitlist control | 0 | 7 | 1 | 7 |
|
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| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |