Adaptive Treatment for Alcohol and Cocaine Dependence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- Treatment Engagement
研究概览
简要总结
- Primary objective #1: Determine the relative effectiveness of MI-IOP and MI-PC in the full study sample with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use over weeks 1-24.
- Hypothesis 1: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce higher rates of treatment engagement than an intervention focused on engagement in IOP only (e.g., MI-IOP).
- Hypothesis 2: An intervention that explores several possible treatment options with the patient and provides the chosen option (e.g., MI-PC) will produce better cocaine/alcohol use outcomes than an intervention focused on engagement in IOP only (MI-IOP).
- Secondary analysis 1: Among the Non-engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option.
- Secondary analysis 2: Among the Engaged patients, determine rates of selection of each of the three options in MI-PC, retention rates within each option, and cocaine/alcohol use outcomes in each option.
- Primary objective #2: Determine whether the relative effectiveness of MI-IOP and MI-PC varies as a function of engagement group, with regard to treatment engagement over weeks 1-12 and cocaine/alcohol use outcomes over weeks 1-24.
- Hypothesis 1: The predicted main effect on retention favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.
- Hypothesis 2: The predicted main effect on cocaine/alcohol use outcomes favoring MI-PC over MI-IOP will be significantly larger among patients in the Non-engaged group than among those in the Engaged group.
详细描述
- Secondary objective #1: Examine outcomes on three secondary measures: percent days abstinent from all substances, negative consequences of drug use, and HIV high risk behaviors.
- Hypothesis 1: Outcomes on the secondary measures will be better in MI-PC than in MI-IOP.
- Secondary objective #2: Test hypotheses concerning potential mediators of the predicted main effect favoring MI-PC over MI-IOP.
- Hypothesis 1: The predicted advantage of MI-PC over MI-IOP will be mediated by greater increases in motivation, self-efficacy, commitment to abstinence, and self-help involvement in MI-PC.
- Secondary objective #3: Test hypotheses concerning effect of additional MI intervention after initial non-engagement persists through 12 weeks.
- Hypothesis 1: A second telephone MI intervention will produce higher rates of subsequent engagement and less cocaine use than no further MI.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •meet DSM-IV criteria for lifetime cocaine or alcohol dependence and have used cocaine or alcohol in the prior 6 months;
- •be > 18 years of age;
- •be judged clinically appropriate for IOP (e.g., no current psychotic disorder or evidence of severe dementia, and no acute medical problem requiring inpatient treatment;
- •have no regular IV heroin use during the past year;
- •have access to a telephone;
- •be willing to be randomized and participate in research; and
- •no current participation in methadone or other forms of DA treatment, other than IOP. Finally, because of study follow-up requirements, subjects will
- •be required to be metropolitan area residents, and
- •be able to provide the name, verified telephone number, and address of at least two contacts who can provide locator information on the patient during follow-up. We will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria.
排除标准
- •have a current psychotic disorder (as assessed with the psychotic screen from the MINI) or evidence of dementia severe enough to prevent participation in outpatient treatment;
- •have acute medical problem requiring immediate inpatient treatment; or
- •are currently participating in methadone or other forms of DA treatment, other than IOP.
研究组 & 干预措施
1-MI-IOP Engaged
Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.
干预措施: Motivational Interviewing (Behavioral)
2-MI-IOP Non-Engaged
Randomized to treatment as usual, and do not attend.
干预措施: Motivational Interviewing (Behavioral)
2-MI-IOP Non-Engaged
Randomized to treatment as usual, and do not attend.
干预措施: Telephone counseling (Behavioral)
2-MI-IOP Non-Engaged
Randomized to treatment as usual, and do not attend.
干预措施: Cognitive Behavioral Therapy (CBT) Counseling (Behavioral)
2-MI-IOP Non-Engaged
Randomized to treatment as usual, and do not attend.
干预措施: medication management (Drug)
2-MI-IOP Non-Engaged
Randomized to treatment as usual, and do not attend.
干预措施: Intensive OutPatient Therapy (Behavioral)
3-MI-PC Engaged
Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
干预措施: Motivational Interviewing (Behavioral)
3-MI-PC Engaged
Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
干预措施: Telephone counseling (Behavioral)
3-MI-PC Engaged
Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
干预措施: Cognitive Behavioral Therapy (CBT) Counseling (Behavioral)
4-MI-PC Non-engaged
Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
干预措施: Motivational Interviewing (Behavioral)
4-MI-PC Non-engaged
Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
干预措施: Telephone counseling (Behavioral)
4-MI-PC Non-engaged
Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
干预措施: Cognitive Behavioral Therapy (CBT) Counseling (Behavioral)
4-MI-PC Non-engaged
Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
干预措施: medication management (Drug)
4-MI-PC Non-engaged
Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
干预措施: Intensive OutPatient Therapy (Behavioral)
结局指标
主要结局
Treatment Engagement
时间窗: weeks 3 - 12
Number of treatment sessions attended
Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks
时间窗: weeks 9 - 12
Number of treatment sessions attended
Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks
时间窗: weeks 9 - 12
Number of treatment sessions attended
Any Drinking Days in Previous Month
时间窗: Month 3 (weeks 9 - 12 post baseline)
Any drinking days during previous month, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Percent Days Drinking
时间窗: Month 6 (weeks 21 - 24)
Percent days of any drinking at follow up, from Time Line Follow Back
Any Drinking
时间窗: Month 6 (weeks 21 - 24 post baseline)
Any drinking at follow up, as reported on Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample drank in the follow up period.
Percent Days Heavy Drinking
时间窗: Month 6 (weeks 21 - 24 post baseline)
Percent days heavy drinking at follow up, from Time Line Follow Back \*heavy drinking is defined as five or more drinks per drinking day for men, four or more for women
Any Heavy Drinking Days
时间窗: Month 6 (weeks 21 - 24 post baseline)
five or more drinks per day for men, four or more drinks per day for women, from Time Line Follow Back. This is a dichotomous measure, so the means that are reported are the percentage of people who have had any days of heavy drinking during the follow up period specified. In other words, 0.57 indicates that 57% of the sample engaged in heavy drinking in the follow up period.
Any Cocaine Use
时间窗: Month 6 (weeks 21 - 24 post baseline)
Any cocaine using self report, binary measure of percent days cocaine use
Percent Days Cocaine Use
时间窗: Month 6 (weeks 21 - 24 post baseline)
Percent days of any cocaine use, self reported
次要结局
未报告次要终点