NCT01556087已完成3 期
Distress Tolerance and Reducing Early Relapse in Buprenorphine Patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- the Client Satisfaction Questionnaire-8
研究概览
简要总结
The investigators propose that inability to tolerate the distress of opioid withdrawal and the negative affect associated with early abstinence are key factors in early illicit opioid lapse and subsequent buprenorphine treatment drop-out. Our intervention aimed at increasing distress tolerance is designed to increase treatment adherence.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •initiating buprenorphine treatment (which requires meeting current criteria for a DSM-IV diagnosis of opioid dependence)
- •plan to remain on buprenorphine for at least three months
- •age between 18 and 65 years
- •if female of childbearing potential -- must be using adequate contraception (an intrauterine device, oral contraceptive, depot contraceptive, a barrier method "every time," or hysterectomy) as assessed by the study physician
- •has at least two persons they regularly contact and can provide contact information for them
- •speaks English sufficiently to understand instructions and assessments.
排除标准
- •current methadone maintenance treatment program participation
- •medically necessary prescription opioid treatment (e.g., for chronic pain)
- •current criteria for a DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, alcohol, stimulants, cocaine, inhalants, hallucinogens
- •a diagnosis of organic brain disorder, bipolar disorder, schizophrenia, schizo-affective, schizophreniform, or paranoid disorder, or major depression (subjects who meet criteria for "substance-induced mood disorder," or dysthymia only will not be excluded)
- •current suicidality on the Modified Scale for Suicidal Ideation
- •use of daily psychotropic, antidepressant, or anxiolytic medication
- •evidence of neuropsychological dysfunction as assessed by the study physician with confirmation with the Folstein Mini-Mental Status Examination
- •anticipated major painful event (significant surgical procedure) in the coming 6 months
- •probation/parole requirements that might interfere with protocol participation
- •history of allergic reaction to buprenorphine or naloxone.
结局指标
主要结局
the Client Satisfaction Questionnaire-8
时间窗: 4 months
assess patient satisfaction with services
buprenorphine treatment adherence
时间窗: 4 months
adherence to buprenorphine treatment, which includes opioid use and risk behaviors, will be assessed
次要结局
- distress tolerance persistence(4 months)
研究者
Michael Stein, MD
Principal Investigator
Butler Hospital
研究点 (2)
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