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Adaptive Treatment for Alcohol and Cocaine Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01032135
First received: December 14, 2009
Last updated: March 28, 2017
Last verified: March 2017
Results First Received: March 28, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Substance Use Disorders
Interventions: Behavioral: Motivational Interviewing
Behavioral: Telephone counseling
Behavioral: Cognitive Behavioral Therapy (CBT) Counseling
Drug: medication management
Behavioral: Intensive OutPatient Therapy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All participants were enrolled when they entered IOP treatment. We collected baseline measures and monitored their treatment attendance. At 2 weeks, we determined whether they were engaged or nonengaged and randomized all participants at that time. Only those that were nonengaged at week 2 and still nonengaged at week 8 were rerandomized at week 8.

Reporting Groups
  Description
Engaged

Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.

This group did not receive any treatment intervention.

MI-PC Non-engaged at 2 Weeks

Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:

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.

Medication management: Prescription for naltrexone

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

MI-IOP Non-Engaged at 2 Weeks

Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.

Randomized to IOP

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

MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks

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

Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.

Telephone counseling: one telephone counseling session per week for 10 weeks.

Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.

Medication Management: Prescription for Naltrexone

MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks

Initially engaged at IOP, but become nonengaged in weeks 3 - 8.

Motivational Interviewing: 2 sessions at time of disengagement.

Return to IOP therapy 3 times weekly for three hours a day

MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks

Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.

Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.

Telephone counseling: one telephone counseling session per week for 10 weeks.

Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.

Medication Management: Prescription for Naltrexone

No Further Intervention

Not engaged at week 2 and still not engaged at week 8.

Randomized to receive no further study intervention.


Participant Flow for 2 periods

Period 1:   2 Week Randomization
    Engaged   MI-PC Non-engaged at 2 Weeks   MI-IOP Non-Engaged at 2 Weeks   MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks   MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks   MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks   No Further Intervention
STARTED   311   93   96   0   0   0   0 
COMPLETED   311   93   96   0   0   0   0 
NOT COMPLETED   0   0   0   0   0   0   0 

Period 2:   8 Week Randomization
    Engaged   MI-PC Non-engaged at 2 Weeks   MI-IOP Non-Engaged at 2 Weeks   MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks   MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks   MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks   No Further Intervention
STARTED   227   0   0   41   43   48   54 
12 Week Follow up   217 [1]   0   0   34   38   36   41 
COMPLETED   201 [1]   0   0   30   34   31   36 
NOT COMPLETED   26   0   0   11   9   17   18 
[1] These participants were'nt included in analyses as they didn't meet criteria for study intervention.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Engaged Participants began treatment in IOP, consistently remained engaged in IOP throughout the study time period. This group did not reach the threshold of needing study intervention.
MI-PC Non-Engaged

Participants began treatment in IOP but were not engaged at week 2. Randomized to receive patient choice.

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.

medication management: Prescription for naltrexone

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

MI-IOP Non-Engaged

Participants began treatment in IOP but were not engaged at week 2. Randomized back to IOP.

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

MI-PC Engaged at 2 Weeks, Non-engaged Before 8 Weeks

Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized to Patient Choice.

Motivational Interviewing: 2 sessions at week 2.

Telephone counseling: one telephone counseling session per week for 10 weeks.

Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.

medication management: Prescription for naltrexone

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

MI-IOP Engaged at 2 Weeks, Non-engaged Before 8 Weeks

Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized back to IOP.

Motivational Interviewing: 2 sessions at week 2.

Total Total of all reporting groups

Baseline Measures
   Engaged   MI-PC Non-Engaged   MI-IOP Non-Engaged   MI-PC Engaged at 2 Weeks, Non-engaged Before 8 Weeks   MI-IOP Engaged at 2 Weeks, Non-engaged Before 8 Weeks   Total 
Overall Participants Analyzed 
[Units: Participants]
 227   93   96   41   43   500 
Age 
[Units: Participants]
Count of Participants
           
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      224  98.7%      91  97.8%      94  97.9%      41 100.0%      43 100.0%      493  98.6% 
>=65 years      3   1.3%      2   2.2%      2   2.1%      0   0.0%      0   0.0%      7   1.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.4  (8.35)   48.02  (9.84)   47.7  (9.38)   47.8  (9.42)   48.5  (9.64)   48.29  (8.92) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      36  15.9%      21  22.6%      21  21.9%      8  19.5%      9  20.9%      95  19.0% 
Male      191  84.1%      72  77.4%      75  78.1%      33  80.5%      34  79.1%      405  81.0% 
Region of Enrollment 
[Units: Participants]
           
United States   227   93   96   41   43   500 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Treatment Engagement   [ Time Frame: weeks 3 - 12 ]

2.  Primary:   Treatment Engagement for Participants Engaged at 2 Weeks, But Disengage Before 8 Weeks   [ Time Frame: weeks 9 - 12 ]

3.  Primary:   Treatment Engagement of Those Non-engaged at 2 Weeks and at 8 Weeks   [ Time Frame: weeks 9 - 12 ]

4.  Primary:   Any Drinking   [ Time Frame: Month 2 ]

5.  Primary:   Any Drinking   [ Time Frame: Month 3 ]

6.  Primary:   Any Drinking   [ Time Frame: Month 4 ]

7.  Primary:   Any Drinking   [ Time Frame: Month 5 ]

8.  Primary:   Any Drinking   [ Time Frame: Month 6 ]

9.  Primary:   Percent Days Drinking   [ Time Frame: Month 2 ]

10.  Primary:   Percent Days Drinking   [ Time Frame: Month 3 ]

11.  Primary:   Percent Days Drinking   [ Time Frame: Month 4 ]

12.  Primary:   Percent Days Drinking   [ Time Frame: Month 5 ]

13.  Primary:   Percent Days Drinking   [ Time Frame: Month 6 ]

14.  Primary:   Any Heavy Drinking Days   [ Time Frame: Month 2 ]

15.  Primary:   Any Heavy Drinking Days   [ Time Frame: Month 3 ]

16.  Primary:   Any Heavy Drinking Days   [ Time Frame: Month 4 ]

17.  Primary:   Any Heavy Drinking Days   [ Time Frame: Month 5 ]

18.  Primary:   Any Heavy Drinking Days   [ Time Frame: Month 6 ]

19.  Primary:   Percent Days Heavy Drinking   [ Time Frame: Month 2 ]

20.  Primary:   Percent Days Heavy Drinking   [ Time Frame: Month 3 ]

21.  Primary:   Percent Days Heavy Drinking   [ Time Frame: Month 4 ]

22.  Primary:   Percent Days Heavy Drinking   [ Time Frame: Month 5 ]

23.  Primary:   Percent Days Heavy Drinking   [ Time Frame: Month 6 ]

24.  Primary:   Any Cocaine Use   [ Time Frame: Month 3 ]

25.  Primary:   Any Cocaine Use   [ Time Frame: Month 4 ]

26.  Primary:   Any Cocaine Use   [ Time Frame: Month 5 ]

27.  Primary:   Any Cocaine Use   [ Time Frame: Month 6 ]

28.  Primary:   Percent Days Cocaine Use   [ Time Frame: Month 3 ]

29.  Primary:   Percent Days Cocaine Use   [ Time Frame: Month 5 ]

30.  Primary:   Percent Days Cocaine Use   [ Time Frame: Month 6 ]

31.  Secondary:   Effect of Patient Choice of Treatment   [ Time Frame: month 6 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: James McKay, PhD
Organization: University of Pennsylvania
phone: 215-746-7704
e-mail: jimrache@mail.med.upenn.edu



Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01032135     History of Changes
Obsolete Identifiers: NCT02689674
Other Study ID Numbers: 807092
IND: 101,486
Study First Received: December 14, 2009
Results First Received: March 28, 2017
Last Updated: March 28, 2017