Trial Outcomes & Findings for Clinical Trial Tobacco Marijuana (NCT NCT02277665)

NCT ID: NCT02277665

Last Updated: 2019-01-08

Results Overview

Percent of Participants who made at least one tobacco quit attempt

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 67 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2019-01-08

Participant Flow

Participants were enrolled between 12/2014 to 09/2016 at Dartmouth College and the University of Washington. Participants were recruited from ads posted online (Craigslist, Facebook), in newspapers, on radio, community posters, and notices to service agencies. All activities occurred at stand-alone, University associated research clinics.

All those who enrolled were assigned to a treatment condition

Participant milestones

Measure	CUD Treatment Only 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD CUD Treatment	CUD and Tobacco Treatment 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco CUD Treatment Tobacco Treatment
Overall Study STARTED	33	34
Overall Study COMPLETED	33	34
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Trial Tobacco Marijuana

Baseline characteristics by cohort

Measure	CUD Treatment Only n=33 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD CUD Treatment	CUD and Tobacco Treatment n=34 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco CUD Treatment Tobacco Treatment	Total n=67 Participants Total of all reporting groups
Age, Continuous	36.3 years STANDARD_DEVIATION 12.2 • n=5 Participants	31.7 years STANDARD_DEVIATION 11.2 • n=7 Participants	34.0 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	23 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	34 participants n=7 Participants	67 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Percent of Participants who made at least one tobacco quit attempt

Outcome measures

Measure	CUD Treatment Only n=33 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD CUD Treatment	CUD and Tobacco Treatment n=34 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco CUD Treatment Tobacco Treatment
Tobacco Quit Attempts	13 Participants	17 Participants

PRIMARY outcome

Timeframe: Weeks 9-12

the percent of participants who achieve sustained tobacco abstinence, which reflects biologically-verified abstinence during weeks 5-12

Outcome measures

Measure	CUD Treatment Only n=33 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD CUD Treatment	CUD and Tobacco Treatment n=34 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco CUD Treatment Tobacco Treatment
Tobacco Abstinence	1 Participants	2 Participants

PRIMARY outcome

Timeframe: Weeks 1-12

number of participants who achieved at least one week of documented cannabis abstinence during treatment

Outcome measures

Measure	CUD Treatment Only n=33 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD CUD Treatment	CUD and Tobacco Treatment n=34 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco CUD Treatment Tobacco Treatment
Cannabis Abstinence	12 Participants	7 Participants

PRIMARY outcome

Timeframe: Weeks 1-12

Population: All participants

Weeks of Continuous Cannabis Abstinence among those achieving at least one week of abstinence

Outcome measures

Measure	CUD Treatment Only n=33 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD CUD Treatment	CUD and Tobacco Treatment n=34 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco CUD Treatment Tobacco Treatment
Weeks of Continuous Cannabis Abstinence	6.1 weeks Standard Deviation 3.7	5.9 weeks Standard Deviation 4.0

PRIMARY outcome

Timeframe: 12 weeks

Attendance operationalized as the number of clinic visits (urine specimens provided)

Outcome measures

Measure	CUD Treatment Only n=33 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD CUD Treatment	CUD and Tobacco Treatment n=34 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco CUD Treatment Tobacco Treatment
Treatment Attendance	11.3 visits Standard Deviation 9.0	9.7 visits Standard Deviation 8.9

PRIMARY outcome

Timeframe: 24 weeks

Population: All participants included in analysis

# of participants who initiated NRT during the 24 week study period

Outcome measures

Measure	CUD Treatment Only n=33 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD CUD Treatment	CUD and Tobacco Treatment n=34 Participants 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco CUD Treatment Tobacco Treatment
Initiation of Nicotine Replacement Therapy (NRT)	6 Participants	14 Participants

Adverse Events

CUD Treatment Only

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

CUD and Tobacco Treatment

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CUD Treatment Only n=33 participants at risk 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD CUD Treatment	CUD and Tobacco Treatment n=34 participants at risk 12 Week Behavioral Treatment that included weekly computer-assisted counseling and contingency management for CUD, and behavioral counseling and nicotine replacement therapy (NRT) for tobacco CUD Treatment Tobacco Treatment
Endocrine disorders pruritus	9.1% 3/33 • Number of events 3 • Two years	14.7% 5/34 • Number of events 5 • Two years

Additional Information

Dr. Alan J. Budney

Dartmouth-Hitchcock

Phone: 603-646-7088

Email: alan.j.budney@dartmouth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place