A Randomized Controlled Trial Comparing Buprenorphine/Naloxone With Naltrexone for Treatment in Opioid Dependent Adolescents and Young Adults
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Retention in treatment: (1-180 days) as measured by the date that participant was last seen by study personnel or date when participant completes study following the date of enrollment.
研究概览
简要总结
This study is designed to determine the relative effectiveness of buprenorphine/naloxone (Suboxone) pharmacotherapy versus naltrexone pharmacotherapy for treatment retention, relapse prevention and opioid craving reduction among opioid-dependent adolescents and young adults. The investigators hypothesize that naltrexone treatment is as effective as buprenorphine/naloxone for these treatment outcomes.
详细描述
Context: Standard treatment of opioid dependence in adolescents is detoxification and counseling, which results in relapse in 20-50% of patients. Alternative medical treatments include buprenorphine and naltrexone that have not been well investigated in adolescents and young adults. Buprenorphine has previously been shown effective in the treatment of opioid dependence in adolescents in one study in the United States as compared to detoxification. Although naltrexone treatment results in low compliance in adults, it is effective in combination with a strong social support network that exists in adolescents that live with at least 1 parent/guardian.
Objective: To compare the efficacy of buprenorphine/naloxone pharmacotherapy with naltrexone pharmacotherapy on treatment retention, relapse prevention and craving reduction among opioid-addicted adolescents and young adults.
Design: 2-arm Randomized Comparative Effectiveness Pharmacotherapy Clinical Trial.
Setting: The study will be conducted in an outpatient treatment facility Participants: The participants will be those who 1) are between 16-25 years old, 2) have clear evidence of a substance use disorder with opioid dependence, and 3) live with at least one parent.
Baseline data collection: Data collected at baseline will include (with examples), demographics (age, gender, race), substance use history (type of substances used, duration of use, routes of abuse), co-existing medical problems (seizures, hepatitis C), prior mental health problems (prior treatment, diagnoses), prior substance abuse treatment (outpatient, inpatient), socioeconomic variables (educational level, occupation, employment history), criminal history (number of arrests and convictions, total amount of time spent in jail or prison), family history (first degree relatives with substance use disorders) and scores on psychometric testing (DAST, opioid craving score).
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
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of Opiate Dependence
- •Successful completion of detoxification
- •can answer 9 out of 10 question correctly that tests understanding of the study
排除标准
- •unable to pay for medication
- •not living with a parent/guardian
- •inability of patient and/or parent to give consent
- •major co-occurring psychiatric disorder
- •existing medical condition that would interfere with the treatment
- •use of CNS depressants
- •pregnancy
研究组 & 干预措施
buprenophine/naloxone
Participants with this arm will receive 4-16 mg/d buprenorphine/naloxone (Suboxone).
干预措施: Buprenorphine/naloxone (Drug)
Naltrexone
Participants assigned to this arm will receive 50 mg/d naltrexone.
干预措施: Naltrexone (Drug)
结局指标
主要结局
Retention in treatment: (1-180 days) as measured by the date that participant was last seen by study personnel or date when participant completes study following the date of enrollment.
时间窗: 6 months
次要结局
- Urine toxicology: (yes/no) at baseline and monthly at 1, 2, 3, 4, 5, 6 months follow-up.(6 months)
- Opioid craving: (1-10) as measured by a 10 point visual analog scale.(6 months)
- Self-reported drug use: (days to first use and percent days abstinent) as measured by time line follow back.(6 months)
研究者
Richard Blondell
MD
State University of New York at Buffalo