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Development and Efficacy Test of Computerized Treatment for Marijuana Dependence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00594659
First Posted: January 16, 2008
Last Update Posted: December 4, 2013
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):
Dartmouth-Hitchcock Medical Center
Results First Submitted: April 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Marijuana Abuse and Dependence
Interventions: Behavioral: Psychotherapy
Behavioral: Computerized Psychotherapy
Behavioral: Motivational enhancement therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment opened in November 2008 and closed in May 2011. Recruitment practices included newspaper and radio advertisements, flyers, and posters distributed in local businesses and agencies. The study took place at an outpatient psychiatry clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were excluded from trial prior to group assignment for at least one of the following:no evidence of marijuana use in at least 40 of the past 90 days prior to enrollment,participant met criteria for dependence on alcohol or illicit drugs,evidence of illicit drug use or K-2 use,interfering medical/psychiatric illness,or active refusal.

Reporting Groups
  Description
1-MET/CBT/CM

Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)

Psychotherapy : Nine session treatment (wks 1-8 and wk 12)

2x/wk urine drug testing

Contingency Management voucher program

2-cMET/CBT/CM

Computer-delievered (c) MET/CBT/CM treatment

Computerized Psychotherapy : Nine session computer delivered treatment

2 times per week urine drug testing

3-tMET

Motivational enhancement therapy

Motivational enhancement therapy : Two session treatment

2x/wk urine drug testing

non-contingent vouchers


Participant Flow:   Overall Study
    1-MET/CBT/CM   2-cMET/CBT/CM   3-tMET
STARTED   29   30   16 
COMPLETED   16   21   9 
NOT COMPLETED   13   9   7 
Lost to Follow-up                13                9                7 



  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
1-MET/CBT/CM

Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)

Nine weekly therapy sessions delivered in weeks 1-8 and week 12

2 times per week urine drug testing

Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test.

2-cMET/CBT/CM

Computer-delievered (c) MET/CBT/CM treatment

Computer delivered nine MET/CBT sessions during weeks 1-8 and week 12. therapist delivered 3 brief supportive counseling sessions during weeks 1, 4, and 12.

2 times per week urine drug testing.

Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test.

3-tMET

Therapist delivered motivational enhancement therapy (tMET)

Two session treatment with sessions delivered during weeks 1 and 4.

Two times per week urine drug testing.

Non-contingent incentives delivered for attending each urine testing appointment.

Total Total of all reporting groups

Baseline Measures
   1-MET/CBT/CM   2-cMET/CBT/CM   3-tMET   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   30   16   75 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   29   30   16   75 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.7  (11.06)   34.87  (11.07)   35  (8.95)   34.85  (10.52) 
Gender 
[Units: Participants]
       
Female   12   14   7   33 
Male   17   16   9   42 
Region of Enrollment 
[Units: Participants]
       
United States   29   30   16   75 
Point prevalence abstinence [1] 
[Units: Percentage of participants]
 0   13   12.5   25.5 
[1] Total percentage column is not accurate because it is automatically summed, which results in an invalid number.


  Outcome Measures
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1.  Primary:   Consecutive Weeks of Marijuana Abstinence   [ Time Frame: From the start of treatment through the end of the active treatment period, i.e., 12 weeks. ]

2.  Primary:   Point Prevalence Abstinence Post Treatment   [ Time Frame: 9 months (from the end of treatment to 9 months post-treatment). ]


  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: Alan J. Budney, PhD Principal Investigator
Organization: Geisel School of Medicine at Dartmouth College
phone: 855-290-2822
e-mail: Alan.J.Budney@dartmouth.edu



Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00594659     History of Changes
Other Study ID Numbers: 88268
1R01DA023526-01 ( U.S. NIH Grant/Contract )
1R01DA023526-02 ( U.S. NIH Grant/Contract )
1R01DA023526-03 ( U.S. NIH Grant/Contract )
First Submitted: January 7, 2008
First Posted: January 16, 2008
Results First Submitted: April 16, 2013
Results First Posted: December 4, 2013
Last Update Posted: December 4, 2013