Trial Outcomes & Findings for Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence (NCT NCT01292642)

Results Overview

cigarettes per day

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Baseline and 10 weeks

Results posted on

2013-08-14

Participant Flow

Subjects were recruited via online and newspaper advertisements.

Four participants were determined to be ineligible due to significant active Axis I psychopathology other than nicotine or cannabis dependence, one was ineligible due to an active medical issue that was referred for treatment, and one was ineligible due to a positive urine toxicology screen for an illicit substance other than cannabis.

Participant milestones

Participant milestones
Measure	Treatment Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.
Overall Study STARTED	12
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=12 Participants CBT plus NRT
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age Continuous	28.2 years STANDARD_DEVIATION 11.0 • n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Region of Enrollment United States	12 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and 10 weeks

cigarettes per day

Outcome measures

Outcome measures
Measure	Baseline - Cigarettes Per Day n=7 Participants	PostTreatment - Cigarettes Per Day n=7 Participants CBT plus NRT
Cigarette Use	12.6 cigarettes/day Standard Deviation 4.9	2.1 cigarettes/day Standard Deviation 4.2

PRIMARY outcome

Timeframe: Baseline and 10 weeks

cannabis inhalations per day

Outcome measures

Outcome measures
Measure	Baseline - Cigarettes Per Day n=7 Participants	PostTreatment - Cigarettes Per Day n=7 Participants CBT plus NRT
Cannabis Use	10.0 cannabis inhalations/day Standard Deviation 5.3	8.0 cannabis inhalations/day Standard Deviation 5.3

SECONDARY outcome

Timeframe: 10 weeks

The Client Satisfaction Questionnaire (CSQ-8) is a self-report instrument used to assess satisfaction with health services and it was used to assess participant satisfaction with the treatment during this 10 week study. Scores range from 8 - 32 with higher values indicating higher satisfaction.

Outcome measures

Outcome measures
Measure	Baseline - Cigarettes Per Day n=7 Participants	PostTreatment - Cigarettes Per Day CBT plus NRT
Client Satisfaction Questionnaire (CSQ-8) at 10 Weeks	30.6 Scores on a scale Standard Deviation 1.9	—

Adverse Events

Treatment

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

Kevin P Hill, MD, MHS

McLean Hospital

Phone: 617-855-4501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place