Testosterone Replacement for Male Opioid Agonist Maintained Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Change in Pain Ratings
研究概览
简要总结
This study is designed to develop an effective treatment intervention for chronic pain, symptomatic hypogonadism, and opioid addiction
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Current suicide or homicide risk
- •Life-threatening or unstable medical condition
- •Known or suspected prostate or chest cancer or history of polycythemia
研究组 & 干预措施
Testosterone replacement
Testosterone replacement for hypogonadism.
干预措施: Testosterone replacement (Drug)
Waitlist control
This arm involves watchful waiting.
干预措施: Waitlist control (Other)
结局指标
主要结局
Change in Pain Ratings
时间窗: 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
时间窗: 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).
Number of Participants Demonstrating Abstinence
时间窗: 8 weeks
Number of participants who provided four consecutive weekly urines that were negative for illicit opioids in weeks 5 through 8.
次要结局
未报告次要终点