Trial Outcomes & Findings for Development and Efficacy Test of Computerized Treatment for Marijuana Dependence (NCT NCT00594659)
NCT ID: NCT00594659
Last Updated: 2013-12-04
Results Overview
Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
From the start of treatment through the end of the active treatment period, i.e., 12 weeks.
Results posted on
2013-12-04
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
30
|
16
|
|
Overall Study
COMPLETED
|
16
|
21
|
9
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
7
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
9
|
7
|
Baseline Characteristics
Development and Efficacy Test of Computerized Treatment for Marijuana Dependence
Baseline characteristics by cohort
| Measure |
1-MET/CBT/CM
n=29 Participants
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
n=30 Participants
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
n=16 Participants
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
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 11.06 • n=5 Participants
|
34.87 years
STANDARD_DEVIATION 11.07 • n=7 Participants
|
35 years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
34.85 years
STANDARD_DEVIATION 10.52 • n=4 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
16 participants
n=5 Participants
|
75 participants
n=4 Participants
|
|
Point prevalence abstinence
|
0 percentage of participants
n=5 Participants
|
13 percentage of participants
n=7 Participants
|
12.5 percentage of participants
n=5 Participants
|
25.5 percentage of participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment through the end of the active treatment period, i.e., 12 weeks.Population: Intent to Treat
Longest period of marijuana abstinence achieved during the 12-week treatment period documented by urine testing and self-report.
Outcome measures
| Measure |
1-tMET/CBT/CM
n=29 Participants
Therapist delivered cognitive behavioral treatment
Psychotherapy : Nine session treatment
|
2-cMET/CBT/CM
n=30 Participants
Computerized Cognitive Behavioral treatment
Computerized Psychotherapy : Nine session computer delivered treatment
|
3-tMET
n=16 Participants
Motivational enhancement therapy
Motivational enhancement therapy : Two session treatment
|
|---|---|---|---|
|
Consecutive Weeks of Marijuana Abstinence
|
3.55 consecutive weeks of abstinence
Standard Deviation 4.39
|
2.82 consecutive weeks of abstinence
Standard Deviation 4.21
|
0.78 consecutive weeks of abstinence
Standard Deviation 1.97
|
PRIMARY outcome
Timeframe: 9 months (from the end of treatment to 9 months post-treatment).Population: Intent to Treat
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).
Outcome measures
| Measure |
1-tMET/CBT/CM
n=29 Participants
Therapist delivered cognitive behavioral treatment
Psychotherapy : Nine session treatment
|
2-cMET/CBT/CM
n=30 Participants
Computerized Cognitive Behavioral treatment
Computerized Psychotherapy : Nine session computer delivered treatment
|
3-tMET
n=16 Participants
Motivational enhancement therapy
Motivational enhancement therapy : Two session treatment
|
|---|---|---|---|
|
Point Prevalence Abstinence Post Treatment
End of Treatment (ETX) Abstinence Rate
|
44.8 pecentage of participants abstinent
|
46.7 pecentage of participants abstinent
|
12.5 pecentage of participants abstinent
|
|
Point Prevalence Abstinence Post Treatment
3-Months Post Treatment Abstinence Rate
|
20.7 pecentage of participants abstinent
|
36.7 pecentage of participants abstinent
|
6.3 pecentage of participants abstinent
|
|
Point Prevalence Abstinence Post Treatment
6-months Post Treatment Abstinence Rate
|
17.2 pecentage of participants abstinent
|
36.7 pecentage of participants abstinent
|
6.3 pecentage of participants abstinent
|
|
Point Prevalence Abstinence Post Treatment
9-months Post Treatment Abstinence Rate
|
10.3 pecentage of participants abstinent
|
23.3 pecentage of participants abstinent
|
6.3 pecentage of participants abstinent
|
Adverse Events
1-MET/CBT/CM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2-cMET/CBT/CM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3-tMET
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alan J. Budney, PhD Principal Investigator
Geisel School of Medicine at Dartmouth College
Phone: 855-290-2822
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place