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Family Based Contingency Management for Adolescent Alcohol Abuse

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ClinicalTrials.gov Identifier: NCT00595478
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Catherine Stanger, Dartmouth-Hitchcock Medical Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Alcohol Abuse
Interventions: Behavioral: Motivational Enhancement Therapy (MET)/CBT+CM
Behavioral: Motivational Enhancement Therapy (MET)/CBT

  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
No text entered.

Reporting Groups
  Description
(MET)/CBT+CM/BPT

Motivational Enhancement Therapy (MET)/CBT+CM/BPT

Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment

(MET)/CBT

Motivational Enhancement Therapy (MET)/CBT

Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment


Participant Flow for 2 periods

Period 1:   Treatment
    (MET)/CBT+CM/BPT   (MET)/CBT
STARTED   37   38 
COMPLETED   37   38 
NOT COMPLETED   0   0 

Period 2:   36-week Follow-up Period
    (MET)/CBT+CM/BPT   (MET)/CBT
STARTED   37   38 
COMPLETED   28   30 
NOT COMPLETED   9   8 
Lost to Follow-up                5                4 
Withdrawal by Subject                4                4 



  Baseline Characteristics

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
(MET)/CBT+CM/BPT

Motivational Enhancement Therapy (MET)/CBT+CM/BPT

Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment

(MET)/CBT

Motivational Enhancement Therapy (MET)/CBT

Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment

Total Total of all reporting groups

Baseline Measures
   (MET)/CBT+CM/BPT   (MET)/CBT   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   38   75 
Age 
[Units: Years]
Mean (Standard Deviation)
 16.1  (1.2)   16.2  (1.2)   16.1  (1.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      10  27.0%      9  23.7%      19  25.3% 
Male      27  73.0%      29  76.3%      56  74.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      6  16.2%      3   7.9%      9  12.0% 
White      29  78.4%      32  84.2%      61  81.3% 
More than one race      0   0.0%      2   5.3%      2   2.7% 
Unknown or Not Reported      2   5.4%      1   2.6%      3   4.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   37   38   75 
Tobacco user 
[Units: Participants]
Count of Participants
 30   30   60 
Mean intake proportion of days used alcohol in past 30 days [1] 
[Units: Proportion of days used alcohol]
Mean (Standard Deviation)
 0.12  (0.16)   0.12  (0.14)   0.12  (0.15) 
[1] We report the proportion of days used because not all participants provided data for the identical number of days at each assessment. Therefore the denominator differs across participants, and the proportion of days on which use was reported is the more appropriate measure of use frequency.
Mean drinks per drinking day 
[Units: Drinks]
Mean (Standard Deviation)
 5.7  (4.9)   6.4  (4.5)   6.0  (4.7) 
DSM Alcohol Use Disorder 
[Units: Participants]
Count of Participants
     
Dependence      7  18.9%      7  18.4%      14  18.7% 
Abuse only      12  32.4%      14  36.8%      26  34.7% 
None      18  48.6%      17  44.7%      35  46.7% 


  Outcome Measures

1.  Primary:   Alcohol Abstinence   [ Time Frame: Weekly up to 14 weeks ]

2.  Secondary:   Days of Alcohol Use During 36-week Follow-up Period   [ Time Frame: Monthly up to 9 months (36 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Catherine Stanger, Ph.D.
Organization: Dartmouth College
phone: 603-646-7023
e-mail: catherine.stanger@dartmouth.edu


Publications of Results:

Responsible Party: Catherine Stanger, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00595478     History of Changes
Other Study ID Numbers: 85846
1R01AA016917-01 ( U.S. NIH Grant/Contract )
1R01AA016917-02 ( U.S. NIH Grant/Contract )
1R01AA016917-03 ( U.S. NIH Grant/Contract )
First Submitted: January 7, 2008
First Posted: January 16, 2008
Results First Submitted: October 30, 2017
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018