Clinical trial NCT01032135: Adaptive Treatment for Alcohol and Cocaine Dependence
Official title: Adaptive Treatment for Alcohol and Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Substance Use Disorders
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2009-12-15
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. 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.
2. 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.

Detailed description: 3. 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.

  4. 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.

  5. 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.

Eligibility criteria: Inclusion Criteria:

1. meet DSM-IV criteria for lifetime cocaine or alcohol dependence and have used cocaine or alcohol in the prior 6 months;
2. be \> 18 years of age;
3. 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;
4. have no regular IV heroin use during the past year;
5. have access to a telephone;
6. be willing to be randomized and participate in research; and
7. no current participation in methadone or other forms of DA treatment, other than IOP. Finally, because of study follow-up requirements, subjects will
8. be required to be metropolitan area residents, and
9. 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.

Exclusion Criteria:

1. 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;
2. have acute medical problem requiring immediate inpatient treatment; or
3. are currently participating in methadone or other forms of DA treatment, other than IOP.

Primary outcomes:
measure: Treatment Engagement
timeFrame: weeks 3 - 12
measure: Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks
timeFrame: weeks 9 - 12
measure: Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks
timeFrame: weeks 9 - 12
measure: Any Drinking Days in Previous Month
timeFrame: Month 2 (weeks 5 - 8 post baseline)
measure: Any Drinking Days in Previous Month
timeFrame: Month 3 (weeks 9 - 12 post baseline)
measure: Any Drinking
timeFrame: Month 4 (weeks 13 - 15 post baseline)
measure: Any Drinking
timeFrame: Month 5 (weeks 16 - 20 post baseline)
measure: Any Drinking
timeFrame: Month 6 (weeks 21 - 24 post baseline)
measure: Percent Days Drinking
timeFrame: Month 2 (weeks 5 - 8 post baseline)
measure: Percent Days Drinking
timeFrame: Month 3 (weeks 9 - 12 post baseline)
measure: Percent Days Drinking
timeFrame: Month 4 (weeks 13 - 16 post baseline)
measure: Percent Days Drinking
timeFrame: Month 5 (weeks 17 - 20 post baseline)
measure: Percent Days Drinking
timeFrame: Month 6 (weeks 21 - 24)
measure: Any Heavy Drinking Days
timeFrame: Month 2 (weeks 5 - 8 post baseline)
measure: Any Heavy Drinking Days
timeFrame: Month 3 (weeks 9 - 12 post baseline)
measure: Any Heavy Drinking Days
timeFrame: Month 4 (weeks 13 - 16 post baseline)
measure: Any Heavy Drinking Days
timeFrame: Month 5 (weeks 17 to 20 post baseline)
measure: Any Heavy Drinking Days
timeFrame: Month 6 (weeks 21 - 24 post baseline)
measure: Percent Days Heavy Drinking
timeFrame: Month 2 (weeks 5 - 8 post baseline)
measure: Percent Days Heavy Drinking
timeFrame: Month 3 (weeks 9 - 12 post baseline)
measure: Percent Days Heavy Drinking
timeFrame: Month 4 (weeks 13 - 16 post baseline)
measure: Percent Days Heavy Drinking
timeFrame: Month 5 ( weeks 17 - 20 post baseline)
measure: Percent Days Heavy Drinking
timeFrame: Month 6 (weeks 21 - 24 post baseline)
measure: Any Cocaine Use
timeFrame: Month 3 (weeks 9 - 12 post baseline)
measure: Any Cocaine Use
timeFrame: Month 4 (weeks 13 - 16 post baseline)
measure: Any Cocaine Use
timeFrame: Month 5 (weeks 17 - 20 post baseline)
measure: Any Cocaine Use
timeFrame: Month 6 (weeks 21 - 24 post baseline)
measure: Percent Days Cocaine Use
timeFrame: Month 3 (weeks 9 - 12 post baseline)
measure: Percent Days Cocaine Use
timeFrame: Month 5 (weeks 17 - 20 post baseline)
measure: Percent Days Cocaine Use
timeFrame: Month 6 (weeks 21 - 24 post baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: VAMC
state: Pennsylvania
city: Philadelphia
country: United States
facility: NorthEast Treatment Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James R. McKay, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: