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Adaptive Treatment for Alcohol and Cocaine Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01032135
First Posted: December 15, 2009
Last Update Posted: September 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pennsylvania
December 14, 2009
December 15, 2009
March 28, 2017
May 15, 2017
September 5, 2017
October 2008
December 2013   (Final data collection date for primary outcome measure)
  • Treatment Engagement [ Time Frame: weeks 3 - 12 ]
    Number of treatment sessions attended
  • Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks [ Time Frame: weeks 9 - 12 ]
    Number of treatment sessions attended
  • Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks [ Time Frame: weeks 9 - 12 ]
    Number of treatment sessions attended
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • Percent Days Drinking [ Time Frame: Month 5 (weeks 17 - 20 post baseline) ]
    Percent days of any drinking at follow up, fromTime Line Follow Back
  • Percent Days Drinking [ Time Frame: Month 6 (weeks 21 - 24) ]
    Percent days of any drinking at follow up, from Time Line Follow Back
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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

  • 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.

  • 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

  • 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

  • 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

  • Any Cocaine Use [ Time Frame: Month 3 (weeks 9 - 12 post baseline) ]
    Any cocaine using self report, binary measure of percent days cocaine use.
  • Any Cocaine Use [ Time Frame: Month 4 (weeks 13 - 16 post baseline) ]
    Any cocaine using self report, binary measure of percent days cocaine use
  • Any Cocaine Use [ Time Frame: Month 5 (weeks 17 - 20 post baseline) ]
    Any cocaine using self report, binary measure of percent days cocaine use
  • Any Cocaine Use [ Time Frame: Month 6 (weeks 21 - 24 post baseline) ]
    Any cocaine using self report, binary measure of percent days cocaine use
  • Percent Days Cocaine Use [ Time Frame: Month 3 (weeks 9 - 12 post baseline) ]
    Percent days of any cocaine use, self reported
  • Percent Days Cocaine Use [ Time Frame: Month 5 (weeks 17 - 20 post baseline) ]
    Percent days of any cocaine use, self reported
  • Percent Days Cocaine Use [ Time Frame: Month 6 (weeks 21 - 24 post baseline) ]
    Percent days of any cocaine use, self reported
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 use over weeks 1-24. [ Time Frame: engagment measured to week 12, cocaine use measured to week 24 ]
Complete list of historical versions of study NCT01032135 on ClinicalTrials.gov Archive Site
Not Provided
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 use outcomes over weeks 1-24. [ Time Frame: Engagement measured until week 12, cocaine use measured until week 24. ]
Not Provided
Not Provided
 
Adaptive Treatment for Alcohol and Cocaine Dependence
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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Substance Use Disorders
  • Behavioral: Motivational Interviewing
    2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.
    Other Name: MI
  • Behavioral: Telephone counseling
    one telephone counseling session per week for 10 weeks.
    Other Name: Telephone based stepped care.
  • Behavioral: Cognitive Behavioral Therapy (CBT) Counseling
    One CBT session per week, for 10 weeks.
    Other Name: CBT
  • Drug: medication management
    Prescription for naltrexone
    Other Name: MM
  • Behavioral: Intensive OutPatient Therapy
    Return to IOP, group therapy 3 times weekly for about three hours a day.
    Other Name: IOP
  • Active Comparator: 1-MI-IOP Engaged
    Randomized to treatment as usual, and they attend regularly but dropped out of treatment after randomization.
    Intervention: Behavioral: Motivational Interviewing
  • Experimental: 2-MI-IOP Non-Engaged
    Randomized to treatment as usual, and do not attend.
    Interventions:
    • Behavioral: Motivational Interviewing
    • Behavioral: Telephone counseling
    • Behavioral: Cognitive Behavioral Therapy (CBT) Counseling
    • Drug: medication management
    • Behavioral: Intensive OutPatient Therapy
  • Active Comparator: 3-MI-PC Engaged
    Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.
    Interventions:
    • Behavioral: Motivational Interviewing
    • Behavioral: Telephone counseling
    • Behavioral: Cognitive Behavioral Therapy (CBT) Counseling
  • Experimental: 4-MI-PC Non-engaged
    Randomized to treatment choice, and do not attend treatment as usual, so the choice option is used.
    Interventions:
    • Behavioral: Motivational Interviewing
    • Behavioral: Telephone counseling
    • Behavioral: Cognitive Behavioral Therapy (CBT) Counseling
    • Drug: medication management
    • Behavioral: Intensive OutPatient Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01032135
807092
IND: 101,486
No
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: James R. McKay, Ph.D University of Pennsylvania
University of Pennsylvania
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP