Chronic Pain, Opioid Addiction, Symptomatic Hypogonadism
Conditions
Keywords
Chronic pain, Opioid addiction, Symptomatic hypogonadism, Testosterone replacement, Opioid agonist maintenance, Methadone, Buprenorphine
Brief summary
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: 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).
Interventions
OTHERWaitlist control
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Testosterone Replacement Testosterone replacement for hypogonadism.
Testosterone replacement | 8 |
| Waitlist Control This arm involves watchful waiting.
Waitlist control | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | Waitlist Control | Testosterone Replacement | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 8 Participants | 15 Participants |
| Age, Continuous | 48 years STANDARD_DEVIATION 11 | 46 years STANDARD_DEVIATION 10 | 47 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 7 participants | 8 participants | 15 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 8 | 1 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Testosterone Replacement | Change in Pain Ratings | 1.8 units on a scale |
| Waitlist Control | Change in Pain Ratings | 1.8 units on a scale |
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).
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Testosterone Replacement | Change in Sexual Dysfunction From Baseline to Week 8 | 6.95 units on a scale | Standard Deviation 1.4 |
| Waitlist Control | Change in Sexual Dysfunction From Baseline to Week 8 | -1 units on a scale | Standard Deviation 1.3 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Testosterone Replacement | Number of Participants Demonstrating Abstinence | 5 Participants |
| Waitlist Control | Number of Participants Demonstrating Abstinence | 4 Participants |