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Development and Efficacy Test of Computerized Treatment for Marijuana Dependence

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ClinicalTrials.gov Identifier: NCT00594659
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : December 4, 2013
Last Update Posted : December 4, 2013
Sponsor:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

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
Enrollment 75
Recruitment Details 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 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.
Arm/Group Title 1-MET/CBT/CM 2-cMET/CBT/CM 3-tMET
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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

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

Computerized Psychotherapy : Nine session computer delivered treatment

2 times per week urine drug testing

Motivational enhancement therapy

Motivational enhancement therapy : Two session treatment

2x/wk urine drug testing

non-contingent vouchers

Period Title: Overall Study
Started 29 30 16
Completed 16 21 9
Not Completed 13 9 7
Reason Not Completed
Lost to Follow-up             13             9             7
Arm/Group Title 1-MET/CBT/CM 2-cMET/CBT/CM 3-tMET Total
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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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 29 30 16 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 16 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
 100.0%
30
 100.0%
16
 100.0%
75
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 30 participants 16 participants 75 participants
34.7  (11.06) 34.87  (11.07) 35  (8.95) 34.85  (10.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 30 participants 16 participants 75 participants
Female
12
  41.4%
14
  46.7%
7
  43.8%
33
  44.0%
Male
17
  58.6%
16
  53.3%
9
  56.3%
42
  56.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 30 participants 16 participants 75 participants
29 30 16 75
Point prevalence abstinence   [1] 
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 29 participants 30 participants 16 participants 75 participants
0 13 12.5 25.5
[1]
Measure Description: Total percentage column is not accurate because it is automatically summed, which results in an invalid number.
1.Primary Outcome
Title Consecutive Weeks of Marijuana Abstinence
Hide Description Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.
Time Frame From the start of treatment through the end of the active treatment period, i.e., 12 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title 1-tMET/CBT/CM 2-cMET/CBT/CM 3-tMET
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Therapist delivered cognitive behavioral treatment

Psychotherapy : Nine session treatment

Computerized Cognitive Behavioral treatment

Computerized Psychotherapy : Nine session computer delivered treatment

Motivational enhancement therapy

Motivational enhancement therapy : Two session treatment

Overall Number of Participants Analyzed 29 30 16
Mean (Standard Deviation)
Unit of Measure: consecutive weeks of abstinence
3.55  (4.39) 2.82  (4.21) 0.78  (1.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1-tMET/CBT/CM, 3-tMET
Comments Pairwise comparison; non-parametric tests performed because of non-normal distribution
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method accelerated bootstrapping
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2-cMET/CBT/CM, 3-tMET
Comments pairwise comparison; non-parametric analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < .05
Comments [Not Specified]
Method accelerated bootstrapping
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 1-tMET/CBT/CM, 2-cMET/CBT/CM
Comments nonparametric pairwise comparison; non-normal distribution
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value > 0.05
Comments [Not Specified]
Method accelerated bootstrapping
Comments [Not Specified]
2.Primary Outcome
Title Point Prevalence Abstinence Post Treatment
Hide Description Percent of participants that were marijuana abstinent based on urine toxicology testing at each follow up assessment across 9 month follow up period ( at the end of treatment, at 3-months, 6-months, and 9 months post the end of treatment).
Time Frame 9 months (from the end of treatment to 9 months post-treatment).
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title 1-tMET/CBT/CM 2-cMET/CBT/CM 3-tMET
Hide Arm/Group Description:

Therapist delivered cognitive behavioral treatment

Psychotherapy : Nine session treatment

Computerized Cognitive Behavioral treatment

Computerized Psychotherapy : Nine session computer delivered treatment

Motivational enhancement therapy

Motivational enhancement therapy : Two session treatment

Overall Number of Participants Analyzed 29 30 16
Measure Type: Number
Unit of Measure: pecentage of participants abstinent
End of Treatment (ETX) Abstinence Rate 44.8 46.7 12.5
3-Months Post Treatment Abstinence Rate 20.7 36.7 6.3
6-months Post Treatment Abstinence Rate 17.2 36.7 6.3
9-months Post Treatment Abstinence Rate 10.3 23.3 6.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1-tMET/CBT/CM, 2-cMET/CBT/CM, 3-tMET
Comments pairwise comparisons among groups across 4 follow-up timepoints
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method piecewise mixed model with logit link an
Comments Performed across all assessments.
Method of Estimation Estimation Parameter Slope
Estimated Value 3.11
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.69
Estimation Comments Slope and p-value above are for group 1: baseline to ETX. Group 3 vs. Group 1 baseline to ETX slope, p < 0.05. All other pairwise comparisons p > 0.05.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1-MET/CBT/CM 2-cMET/CBT/CM 3-tMET
Hide Arm/Group Description

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

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

Computerized Psychotherapy : Nine session computer delivered treatment

2 times per week urine drug testing

Motivational enhancement therapy

Motivational enhancement therapy : Two session treatment

2x/wk urine drug testing

non-contingent vouchers

All-Cause Mortality
1-MET/CBT/CM 2-cMET/CBT/CM 3-tMET
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1-MET/CBT/CM 2-cMET/CBT/CM 3-tMET
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/30 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1-MET/CBT/CM 2-cMET/CBT/CM 3-tMET
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/30 (0.00%)   0/16 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Alan J. Budney, PhD Principal Investigator
Organization: Geisel School of Medicine at Dartmouth College
Phone: 855-290-2822
EMail: Alan.J.Budney@dartmouth.edu
Layout table for additonal information
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