Adaptive Treatment for Alcohol Dependence

Alcohol Dependence Clinical Trial

Official title:

Adaptive Treatment for Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689674
• Other study ID #: 807985
• Secondary ID: 1P01AA016821-01A
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 9, 2016
• Last updated: February 23, 2016
• Start date: February 2009
• Est. completion date: December 2013

Study information

• Verified date: February 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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 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 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 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 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 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 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.

Description:

3. Secondary objective #1: Examine outcomes on three secondary measures: percent days abstinent from all substances, nega¬tive consequences of alcohol 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 alcohol use than no further MI.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• meet DSM-IV criteria for lifetime alcohol dependence and have used 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;

• 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 alcohol dependent and meet other inclusion criteria.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• Naltrexone
pills, 50mgs per day, taken for 10 weeks.

Behavioral:
• Motivational Interviewing
2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
• Telephone counseling
one telephone counseling session per week for 10 weeks.
• Cognitive Behavioral Therapy (CBT) Counseling
One CBT session per week, for 10 weeks.

Locations

Country	Name	City	State
United States	Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	VAMC	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Attendance measured in days of treatment attended.		engagement measured to week 12	No
Secondary	Percent days drinking, measured as a percentage of days reported drinking out of available days.		alcohol use measured until week 24	No