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Completed

NCT Number: NCT01032135

Adaptive Treatment for Alcohol and Cocaine Dependence

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.

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

NorthEast Treatment Center, Philadelphia, Pennsylvania, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Motivational Interviewing

Behavioral

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

Other names: MI

Telephone counseling

Behavioral

one telephone counseling session per week for 10 weeks.

Other names: Telephone based stepped care.

Cognitive Behavioral Therapy (CBT) Counseling

Behavioral

One CBT session per week, for 10 weeks.

Other names: CBT

medication management

Drug

Prescription for naltrexone

Other names: MM

Intensive OutPatient Therapy

Behavioral

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

Other names: IOP

Primary outcomes

  1. Treatment Engagement

    Time frame: weeks 3 - 12

    Number of treatment sessions attended

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

    Time frame: weeks 9 - 12

    Number of treatment sessions attended

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

    Time frame: weeks 9 - 12

    Number of treatment sessions attended

  4. Any Drinking Days in Previous Month

    Time frame: Month 2 (weeks 5 - 8 post baseline)

    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.

  5. Any Drinking Days in Previous Month

    Time frame: 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.

  6. Any Drinking

    Time frame: Month 4 (weeks 13 - 15 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.

  7. Any Drinking

    Time frame: Month 5 (weeks 16 - 20 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.

  8. Any Drinking

    Time frame: 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.

  9. Percent Days Drinking

    Time frame: Month 2 (weeks 5 - 8 post baseline)

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

  10. Percent Days Drinking

    Time frame: Month 3 (weeks 9 - 12 post baseline)

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

  11. Percent Days Drinking

    Time frame: Month 4 (weeks 13 - 16 post baseline)

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

  12. Percent Days Drinking

    Time frame: Month 5 (weeks 17 - 20 post baseline)

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

  13. Percent Days Drinking

    Time frame: Month 6 (weeks 21 - 24)

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

  14. Any Heavy Drinking Days

    Time frame: Month 2 (weeks 5 - 8 post baseline)

    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.

  15. Any Heavy Drinking Days

    Time frame: Month 3 (weeks 9 - 12 post baseline)

    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.

  16. Any Heavy Drinking Days

    Time frame: Month 4 (weeks 13 - 16 post baseline)

    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.

  17. Any Heavy Drinking Days

    Time frame: Month 5 (weeks 17 to 20 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.

  18. Any Heavy Drinking Days

    Time frame: 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.

  19. Percent Days Heavy Drinking

    Time frame: Month 2 (weeks 5 - 8 post baseline)

    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

  20. Percent Days Heavy Drinking

    Time frame: Month 3 (weeks 9 - 12 post baseline)

    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.

  21. Percent Days Heavy Drinking

    Time frame: Month 4 (weeks 13 - 16 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

  22. Percent Days Heavy Drinking

    Time frame: Month 5 ( weeks 17 - 20 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

  23. Percent Days Heavy Drinking

    Time frame: 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

  24. Any Cocaine Use

    Time frame: Month 3 (weeks 9 - 12 post baseline)

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

  25. Any Cocaine Use

    Time frame: Month 4 (weeks 13 - 16 post baseline)

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

  26. Any Cocaine Use

    Time frame: Month 5 (weeks 17 - 20 post baseline)

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

  27. Any Cocaine Use

    Time frame: Month 6 (weeks 21 - 24 post baseline)

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

  28. Percent Days Cocaine Use

    Time frame: Month 3 (weeks 9 - 12 post baseline)

    Percent days of any cocaine use, self reported

  29. Percent Days Cocaine Use

    Time frame: Month 5 (weeks 17 - 20 post baseline)

    Percent days of any cocaine use, self reported

  30. Percent Days Cocaine Use

    Time frame: Month 6 (weeks 21 - 24 post baseline)

    Percent days of any cocaine use, self reported

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 15, 2009
Registry last updated
Sep 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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