Treatment of Cocaine Addiction With Integrative Meditation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- Measurement of cocaine urine toxicology from baseline to 3 month follow-up
研究概览
简要总结
Cocaine addiction continues to be a major problem in the U.S. with no FDA-approved pharmaceutical therapy. Finding effective treatment for cocaine addiction has long been a challenge to scientists and clinicians. Psychosocial interventions known as behavior therapies are the cornerstone of cocaine addiction treatment. However, there is an urgent need to further improve treatment outcomes, especially during early recovery and the protracted withdrawal phase of the treatment since many patients drop out or relapse during this phase. Our clinical experience and studies suggest that integrative Meditation (IM) helps reduce cravings and withdrawal symptoms and increases treatment retention. The benefit of IM is well supported by tension-reduction theory and attention-networks framework in addiction treatment. The proposed study will implement a therapy development study to add IM as a self-care component to the current outpatient treatment of cocaine addiction to improve treatment outcomes.
The specific aims of the proposed study include: 1) to conduct a 12-week controlled trial with outpatient cocaine users to assess feasibility of recruiting and retaining cocaine addicts and to determine effect size of IM-augmented treatment in comparison with Nondirective Therapy (NT) control, with both groups receiving standard outpatient treatment as usual (TAU), thereby facilitating future larger scale therapy development study; and 2) to examine the changes in attention networks and negative mood as possible mediators of treatment outcomes between the two groups.
详细描述
Randomization Procedure:
Subjects who meet DSM-IV cocaine dependence or abuse and other inclusion criteria will be randomly assigned to an IM or NT group, using an adaptive urn randomization procedure, which adjusts for gender, referral source (self-referred or count-mandated), psychiatric medication (yes/no), and type of cocaine addiction (polydrug vs. cocaine only). Simple randomization may not be adequate to assure a balance between the groups of known predictive indicators. While the primary basis of assignment remains randomization, urn randomization biases assignment towards balance between groups based on variables known to be related to treatment outcome when sample sizes are intermediate. Randomization reduces the possibility that one group will be assigned a disproportionate number of the few patients in certain subgroup.
Overview of the Treatment Procedure Twelve treatment sessions over 12 weeks will occur in the outpatient facility once a week, about 30 minutes each session. Treatment outcomes will be assessed at weeks 4, 8, 12, and 24 (3 months after treatment). The follow-up assessments can occur either at the outpatient facility, or at our offices in University of Maryland (Kernan Hospital). We will make the follow-up sessions at both sites equivalent to each other, and provide financial compensation for individuals who travel to our campus. For those who do not want to come to the University, we will ensure that the follow-up sessions at the treatment facility will be held in a private room separate from the location of staff and patients to ensure privacy. Subjects are clearly assured that no one at the treatment facility will have access to their treatment outcome data.
We considered having the same therapists deliver both treatments to limit therapist-specific effects independent of the actual treatment condition. Upon further consideration, we decided that this approach could potentially lead to overlap in the delivery of the two treatments and/or unintentional biases in the implementation of the control treatment. Therefore, we decided to have a total of four therapists of similar experience. Two will deliver the IM therapy, and other two will provide NT. The therapists for both groups will have similar qualifications. To prevent bias, the therapists of NT will be blinded to the study hypotheses. Treatment fidelity will be monitored through sample audio records of selected sessions to ensure the separation of treatment protocols. If diffusion occurs, further training will be utilized. To further prevent bias, none of the therapists will be involved in outcome assessment, and they will be blind to participant responses. Assessment measures will be conducted by research staff available for the study.
Description of IM Treatment Procedure Basically, IM with RFB is a combining transitions behavior therapy designed for different stages of addiction treatment. Following three stages and corresponding treatment contents will be included in the 12-week treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meets DSM-IV criteria for cocaine dependence or abuse and seeks addiction treatment
- •age 18 or older
- •used cocaine in the past 3 weeks, and cocaine is one of the major abused substances if using multiple drugs (urine cocaine positive at least once in the past 3 urine tests)
- •is willing to adhere to the study protocol (e.g. provide urine samples, attend all visits and follow-ups in the next 6 months).
排除标准
- •poses a current suicidal risk, including active suicidal ideation, recent suicidal behavior or suicide attempt in the past 30 days
- •has a history of schizophrenia or other psychotic disorder
- •unable to read or understand questions in English
- •currently participates in other clinical study on addiction
结局指标
主要结局
Measurement of cocaine urine toxicology from baseline to 3 month follow-up
时间窗: 3 month follow-up
次要结局
- Compare participants' use of drugs and alcohol from baseline to 3 month follow-up(3 month follow-up)
- Compare heart rate variability from baseline to 4 weeks(4 weeks)
- Change in Spielberger State-Trait Anxiety Inventory state version (STAI) composite scores from 4 weeks to 8 weeks(8 weeks)
- Change in Self-efficacy and Self-esteem (SES) composite scores from 4 weeks to 8 weeks(8 weeks)
- Change in participants' weekly Spielberger State-Trait Anxiety Inventory state version (STAI) composite scores from baseline to 4 weeks(4 weeks)
- Compare heart rate variability from 4 weeks to 8 weeks(8 weeks)
- Compare heart rate variability from 12 weeks to 3 month follow-up(3 month follow-up)
- Compare participants' cocaine cravings from 8 weeks to 12 weeks(12 weeks)
- Compare heart rate variability from 8 weeks to 12 weeks(12 weeks)
- Track participant's length of time in a drug treatment program from baseline to 4 weeks(4 weeks)
- Track participant's length of time in a drug treatment program from 4 weeks to 8 weeks(8 weeks)
- Compare participants' cocaine cravings from 12 weeks to 3 month follow-up(3 month follow-up)
- Change in Beck Depression Inventory-II (BDI-II) composite scores from 8 weeks to 12 weeks(12 weeks)
- Change in Self-efficacy and Self-esteem (SES) composite scores from 8 weeks to 12 weeks(12 weeks)
- Change in Addiction Severity Index (ASI lite) composite scores from baseline to 3 month follow-up(3 month follow-up)
- Compare participants' weekly cocaine cravings from baseline to 4 weeks(4 weeks)
- Compare participants' cocaine cravings from 4 weeks to 8 weeks(8 weeks)
- Change in Beck Depression Inventory-II (BDI-II) composite scores from 12 weeks to 3 month follow-up(3 month follow-up)
- Change in Spielberger State-Trait Anxiety Inventory state version (STAI) composite scores from 12 weeks to 3 month follow-up(3 month follow-up)
- Change in Self-efficacy and Self-esteem (SES) composite scores from baseline to 4 weeks(4 weeks)
- Change in Beck Depression Inventory-II (BDI-II) composite scores from baseline to 4 weeks(4 weeks)
- Change in Beck Depression Inventory-II (BDI-II) composite scores from 4 weeks to 8 weeks(8 weeks)
- Track participant's length of time in a drug treatment program from 8 weeks to 12 weeks(12 weeks)
- Change in Spielberger State-Trait Anxiety Inventory state version (STAI) composite scores from 8 weeks to 12 weeks(12 weeks)
- Change in Self-efficacy and Self-esteem (SES) composite scores from 12 weeks to 3 month follow-up(3 month follow-up)
研究者
Mary Bahr-Robertson
Research Supervisor
University of Maryland, Baltimore