Adaptive Treatment for Alcohol and Cocaine Dependence

NCT01032135 | Completed Phase 2 Results

• 2 other identifiers: 807092IND: 101,486
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

• 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.

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (30)

• Treatment Engagement

  Number of treatment sessions attended

  weeks 3 - 12

• Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks

  Number of treatment sessions attended

  weeks 9 - 12

• Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks

  Number of treatment sessions attended

  weeks 9 - 12

• Any Drinking Days in Previous Month

  Days of any drinking in 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.

  Month 2 (weeks 5 - 8 post baseline)

• Any Drinking Days in Previous Month

  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.

  Month 3 (weeks 9 - 12 post baseline)

• Any Drinking

  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.

  Month 4 (weeks 13 - 15 post baseline)

• Any Drinking

  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.

  Month 5 (weeks 16 - 20 post baseline)

• Any Drinking

  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.

  Month 6 (weeks 21 - 24 post baseline)

• Percent Days Drinking

  Percent days of any drinking at follow up, from Time Line Follow Back

  Month 2 (weeks 5 - 8 post baseline)

• Percent Days Drinking

  Percent days of any drinking at follow up, from Time Line Follow Back

  Month 3 (weeks 9 - 12 post baseline)

• Percent Days Drinking

  Percent days of any drinking at follow up, from Time Line Follow Back

  Month 4 (weeks 13 - 16 post baseline)

• Percent Days Drinking

  Percent days of any drinking at follow up, fromTime Line Follow Back

  Month 5 (weeks 17 - 20 post baseline)

• Percent Days Drinking

  Percent days of any drinking at follow up, from Time Line Follow Back

  Month 6 (weeks 21 - 24)

• Any Heavy Drinking Days

  days of five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, 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.

  Month 2 (weeks 5 - 8 post baseline)

• Any Heavy Drinking Days

  five or more drinks per drinking day for men, four or more drinks per drinking day for women, at follow up, 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.

  Month 3 (weeks 9 - 12 post baseline)

• Any Heavy Drinking Days

  five or more drinks per drinking day for men, four or more drinks per drinking day for women at follow up, 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.

  Month 4 (weeks 13 - 16 post baseline)

• Any Heavy Drinking Days

  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.

  Month 5 (weeks 17 to 20 post baseline)

• Any Heavy Drinking Days

  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.

  Month 6 (weeks 21 - 24 post baseline)

• Percent Days Heavy Drinking

  Percent days heavy drinking at follow up, from Time Line Follow Back \*heavy drinking is defined as five or more drinks per day for men, four or more for women

  Month 2 (weeks 5 - 8 post baseline)

• Percent Days Heavy Drinking

  Percent days heavy drinking at follow up, from Time Line Follow Back \* heavy drinking is defined as five or more drinks per day for men, four or more for women.

  Month 3 (weeks 9 - 12 post baseline)

• Percent Days Heavy Drinking

  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

  Month 4 (weeks 13 - 16 post baseline)

• Percent Days Heavy Drinking

  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

  Month 5 ( weeks 17 - 20 post baseline)

• Percent Days Heavy Drinking

  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

  Month 6 (weeks 21 - 24 post baseline)

• Any Cocaine Use

  Any cocaine using self report, binary measure of percent days cocaine use.

  Month 3 (weeks 9 - 12 post baseline)

• Any Cocaine Use

  Any cocaine using self report, binary measure of percent days cocaine use

  Month 4 (weeks 13 - 16 post baseline)

• Any Cocaine Use

  Any cocaine using self report, binary measure of percent days cocaine use

  Month 5 (weeks 17 - 20 post baseline)

• Any Cocaine Use

  Any cocaine using self report, binary measure of percent days cocaine use

  Month 6 (weeks 21 - 24 post baseline)

• Percent Days Cocaine Use

  Percent days of any cocaine use, self reported

  Month 3 (weeks 9 - 12 post baseline)

• Percent Days Cocaine Use

  Percent days of any cocaine use, self reported

  Month 5 (weeks 17 - 20 post baseline)

• Percent Days Cocaine Use

  Percent days of any cocaine use, self reported

  Month 6 (weeks 21 - 24 post baseline)

Study Arms (4)

1-MI-IOP Engaged

ACTIVE COMPARATOR

Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.

Behavioral: Motivational Interviewing

2-MI-IOP Non-Engaged

EXPERIMENTAL

Randomized to treatment as usual, and do not attend.

Behavioral: Motivational Interviewing; Behavioral: Telephone counseling; Behavioral: Cognitive Behavioral Therapy (CBT) Counseling; Drug: medication management; Behavioral: Intensive OutPatient Therapy

3-MI-PC Engaged

ACTIVE COMPARATOR

Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.

Behavioral: Motivational Interviewing; Behavioral: Telephone counseling; Behavioral: Cognitive Behavioral Therapy (CBT) Counseling

4-MI-PC Non-engaged

EXPERIMENTAL

Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.

Behavioral: Motivational Interviewing; Behavioral: Telephone counseling; Behavioral: Cognitive Behavioral Therapy (CBT) Counseling; Drug: medication management; Behavioral: Intensive OutPatient Therapy

Interventions

Motivational Interviewing BEHAVIORAL

2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.

Also known as: MI

1-MI-IOP Engaged; 2-MI-IOP Non-Engaged; 3-MI-PC Engaged; 4-MI-PC Non-engaged

Telephone counseling BEHAVIORAL

one telephone counseling session per week for 10 weeks.

Also known as: Telephone based stepped care.

2-MI-IOP Non-Engaged; 3-MI-PC Engaged; 4-MI-PC Non-engaged

Cognitive Behavioral Therapy (CBT) Counseling BEHAVIORAL

One CBT session per week, for 10 weeks.

Also known as: CBT

2-MI-IOP Non-Engaged; 3-MI-PC Engaged; 4-MI-PC Non-engaged

medication management DRUG

Prescription for naltrexone

Also known as: MM

2-MI-IOP Non-Engaged; 4-MI-PC Non-engaged

Intensive OutPatient Therapy BEHAVIORAL

Return to IOP, group therapy 3 times weekly for about three hours a day.

Also known as: IOP

2-MI-IOP Non-Engaged; 4-MI-PC Non-engaged

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (3)

Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

VAMC

Philadelphia, Pennsylvania, 19104, United States

Location

NorthEast Treatment Center

Philadelphia, Pennsylvania, 19123, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Motivational Interviewing; Cognitive Behavioral Therapy; Counseling; Medication Therapy Management

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy; Community Health Services; Pharmaceutical Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: James McKay, PhD
• Organization: University of Pennsylvania

jimrache@mail.med.upenn.edu

215-746-7704

Study Officials

• James R. McKay, Ph.D

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2009
• First Posted: December 15, 2009
• Study Start: October 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 5, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-08

Locations

US (3)