Trial Outcomes & Findings for Treatment for Adolescent Marijuana Abuse (NCT NCT00580671)

Results Overview

Percentage of participants who achieved 2 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

153 participants

Primary outcome timeframe

Testing done twice weekly for 14 weeks.

Results posted on

2015-08-20

Participant Flow

Recruitment opened in November 2007 and closed in February 2011. Participants were referred to the study for substance abuse treatment by school administrators, the juvenile justice system, community therapists, physicians or were self-referred. The study took place at an outpatient psychiatry clinic.

Clients were enrolled into the study and assessed for eligibility, if eligible they were given the choice to proceed. Reasons for ineligibility included no marijuana (MJ) use in past 30 days, failure to meet MJ abuse/dependence criteria, met dependence for another substance, no parent participant, plans to move away, low IQ

Participant milestones

Participant milestones
Measure	MET/CBT+CM/BPT Motivational Enhancement Therapy (MET)/ Cognitive Behavior Therapy (CBT) + Contingency Management (CM) / Behavioral Parent Training (BPT)	MET/CBT+CM Motivational Enhancement Therapy (MET)/CBT+CM	MET/CBT Motivational Enhancement Therapy (MET)/CBT
Overall Study STARTED	51	51	51
Overall Study COMPLETED	35	35	34
Overall Study NOT COMPLETED	16	16	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment for Adolescent Marijuana Abuse

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MET/CBT+CM/BPT n=51 Participants Motivational Enhancement Therapy (MET)/CBT+CM/BPT	MET/CBT+CM n=51 Participants Motivational Enhancement Therapy (MET)/CBT+CM	MET/CBT n=51 Participants Motivational Enhancement Therapy (MET)/CBT	Total n=153 Participants Total of all reporting groups
Age, Categorical <=18 years	51 Participants n=5 Participants	51 Participants n=7 Participants	51 Participants n=5 Participants	153 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 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	15.8 years STANDARD_DEVIATION 1.4 • n=5 Participants	15.9 years STANDARD_DEVIATION 1.3 • n=7 Participants	15.7 years STANDARD_DEVIATION 1.3 • n=5 Participants	15.8 years STANDARD_DEVIATION 1.4 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	45 Participants n=7 Participants	47 Participants n=5 Participants	136 Participants n=4 Participants
Region of Enrollment United States	51 participants n=5 Participants	51 participants n=7 Participants	51 participants n=5 Participants	153 participants n=4 Participants

PRIMARY outcome

Timeframe: Testing done twice weekly for 14 weeks.

Percentage of participants who achieved 2 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.

Outcome measures

Outcome measures
Measure	MET/CBT+CM/BPT n=51 Participants Motivational Enhancement Therapy (MET)/CBT+CM/BPT	MET/CBT+CM n=51 Participants Motivational Enhancement Therapy (MET)/CBT+CM	MET/CBT n=51 Participants Motivational Enhancement Therapy (MET)/CBT
Marijuana Abstinence (2 Weeks or Greater)	72.5 percentage of participants	68.6 percentage of participants	45.1 percentage of participants

PRIMARY outcome

Timeframe: Twice weekly urine tests for 14 weeks.

Percentage of participants who achieved 4 continuous weeks of marijuana abstinence as verified by twice weekly urine testing during the 14 weeks of treatment.

Outcome measures

Outcome measures
Measure	MET/CBT+CM/BPT n=51 Participants Motivational Enhancement Therapy (MET)/CBT+CM/BPT	MET/CBT+CM n=51 Participants Motivational Enhancement Therapy (MET)/CBT+CM	MET/CBT n=51 Participants Motivational Enhancement Therapy (MET)/CBT
Marijuana Abstinence (4 Weeks or Greater)	58.8 percentage of participants	64.7 percentage of participants	35.3 percentage of participants

SECONDARY outcome

Timeframe: This is for the proportion of days abstinent across the entire 14-week treatment period. Self-report data are collected twice weekly during treatment to obtain a cumulative proportion

Population: Those participants with data on at least 80 days of the 91 days of treatment were used in this analysis.

This reflects the mean proportion of days of marijuana abstinence for each participant

Outcome measures

Outcome measures
Measure	MET/CBT+CM/BPT n=49 Participants Motivational Enhancement Therapy (MET)/CBT+CM/BPT	MET/CBT+CM n=44 Participants Motivational Enhancement Therapy (MET)/CBT+CM	MET/CBT n=45 Participants Motivational Enhancement Therapy (MET)/CBT
Proportion of Days of Marijuana Abstinence Across All Days of Treatment (14 Weeks)	.8058 proportion of marijuana abstinent days Standard Deviation .29419	.8162 proportion of marijuana abstinent days Standard Deviation .29143	.7915 proportion of marijuana abstinent days Standard Deviation .26115

Adverse Events

MET/CBT+CM/BPT

Serious events: 15 serious events

Other events: 7 other events

Deaths: 0 deaths

MET/CBT+CM

Serious events: 8 serious events

Other events: 8 other events

Deaths: 0 deaths

MET/CBT

Serious events: 6 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MET/CBT+CM/BPT n=51 participants at risk Motivational Enhancement Therapy (MET)/CBT+CM/BPT	MET/CBT+CM n=51 participants at risk Motivational Enhancement Therapy (MET)/CBT+CM	MET/CBT n=51 participants at risk Motivational Enhancement Therapy (MET)/CBT
Psychiatric disorders Residential Treatment for Substance Use	7.8% 4/51 • Number of events 4	2.0% 1/51 • Number of events 1	3.9% 2/51 • Number of events 2
Psychiatric disorders Hospitatlization or Residential Treatment for Mental Health	11.8% 6/51 • Number of events 6	2.0% 1/51 • Number of events 1	2.0% 1/51 • Number of events 1
General disorders Boot Camp, Detention, Incarceration	7.8% 4/51 • Number of events 4	11.8% 6/51 • Number of events 7	5.9% 3/51 • Number of events 4
General disorders Overdose	2.0% 1/51 • Number of events 1	0.00% 0/51	0.00% 0/51

Other adverse events

Other adverse events
Measure	MET/CBT+CM/BPT n=51 participants at risk Motivational Enhancement Therapy (MET)/CBT+CM/BPT	MET/CBT+CM n=51 participants at risk Motivational Enhancement Therapy (MET)/CBT+CM	MET/CBT n=51 participants at risk Motivational Enhancement Therapy (MET)/CBT
General disorders Arrested	3.9% 2/51 • Number of events 2	5.9% 3/51 • Number of events 3	2.0% 1/51 • Number of events 1
General disorders Running Away	5.9% 3/51 • Number of events 3	3.9% 2/51 • Number of events 2	0.00% 0/51
General disorders Expelled from School	3.9% 2/51 • Number of events 2	3.9% 2/51 • Number of events 2	3.9% 2/51 • Number of events 2
General disorders Dropped Out of School	0.00% 0/51	2.0% 1/51 • Number of events 1	0.00% 0/51
General disorders DCFS Report	0.00% 0/51	0.00% 0/51	2.0% 1/51 • Number of events 1

Additional Information

Alan J. Budney, PhD

Geisel School of Medicine at Dartmouth

Phone: 855-290-2822

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place