Trial Outcomes & Findings for Enhancing a High School Based Smoking Cessation Program (NCT NCT01145001)

Last Updated: 2016-12-29

Results Overview

Our primary outcome will be point prevalence abstinence at the end of the treatment period defined as any self-report of cigarette use during the seven days prior to the last appointment confirmed by urine analysis.

Recruitment status

COMPLETED

Study phase

Target enrollment

154 participants

Primary outcome timeframe

6 weeks

Results posted on

2016-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	Active Nicotine Patch and Contingency Management Subjects in this group will receive Contingency Management and active nicotine patch Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day	Nicotine Patch With no Contingency Management Subjects in this group will receive active nicotine patch without contingency management for abstinence Cognitive Behavioural Therapy: Weekly CBT for all subjects Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day	Placebo Patch and Contingency Management Subjects in this group will receive a placebo transdermal patch and contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis	Placebo Patch and no Contingency Management Subjects in this group will receive a placebo patch and will not receive contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects
Overall Study STARTED	36	37	44	37
Overall Study COMPLETED	28	31	39	31
Overall Study NOT COMPLETED	8	6	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Enhancing a High School Based Smoking Cessation Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Nicotine Patch and Contingency Management n=36 Participants Subjects in this group will receive Contingency Management and active nicotine patch Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day	Nicotine Patch With no Contingency Management n=37 Participants Subjects in this group will receive active nicotine patch without contingency management for abstinence Cognitive Behavioural Therapy: Weekly CBT for all subjects Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day	Placebo Patch and Contingency Management n=44 Participants Subjects in this group will receive a placebo transdermal patch and contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis	Placebo Patch and no Contingency Management n=37 Participants Subjects in this group will receive a placebo patch and will not receive contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects	Total n=154 Participants Total of all reporting groups
Age, Categorical <=18 years	34 Participants n=5 Participants	36 Participants n=7 Participants	42 Participants n=5 Participants	37 Participants n=4 Participants	149 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 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	0 Participants n=21 Participants
Age, Continuous	16.53 years STANDARD_DEVIATION 1.276 • n=5 Participants	16.62 years STANDARD_DEVIATION 1.233 • n=7 Participants	16.66 years STANDARD_DEVIATION 1.01 • n=5 Participants	16.30 years STANDARD_DEVIATION 1.151 • n=4 Participants	16.53 years STANDARD_DEVIATION 1.161 • n=21 Participants
Gender Female	11 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	17 Participants n=4 Participants	59 Participants n=21 Participants
Gender Male	25 Participants n=5 Participants	23 Participants n=7 Participants	27 Participants n=5 Participants	20 Participants n=4 Participants	95 Participants n=21 Participants
Region of Enrollment United States	36 participants n=5 Participants	37 participants n=7 Participants	44 participants n=5 Participants	37 participants n=4 Participants	154 participants n=21 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Active Nicotine Patch and Contingency Management n=36 Participants Subjects in this group will receive Contingency Management and active nicotine patch Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day	Nicotine Patch With no Contingency Management n=37 Participants Subjects in this group will receive active nicotine patch without contingency management for abstinence Cognitive Behavioural Therapy: Weekly CBT for all subjects Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day	Placebo Patch and Contingency Management n=44 Participants Subjects in this group will receive a placebo transdermal patch and contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis	Placebo Patch and no Contingency Management n=37 Participants Subjects in this group will receive a placebo patch and will not receive contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects
Abstinence Rates at the End of Treatment	35.1 percentage of participants not smoking	24.3 percentage of participants not smoking	38.6 percentage of participants not smoking	36.1 percentage of participants not smoking

SECONDARY outcome

Timeframe: 6 weeks

Population: this is the intent to treat group-all starters (not treatment completers)

We will also examine continuous abstinence during the six week treatment period by urine analysis each week.

Outcome measures

Outcome measures
Measure	Active Nicotine Patch and Contingency Management n=42 Participants Subjects in this group will receive Contingency Management and active nicotine patch Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day	Nicotine Patch With no Contingency Management n=34 Participants Subjects in this group will receive active nicotine patch without contingency management for abstinence Cognitive Behavioural Therapy: Weekly CBT for all subjects Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day	Placebo Patch and Contingency Management n=35 Participants Subjects in this group will receive a placebo transdermal patch and contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis	Placebo Patch and no Contingency Management n=32 Participants Subjects in this group will receive a placebo patch and will not receive contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects
Continuous Abstinence During Treatment	26.1 consecutive days of abstinence Standard Deviation 14.1	26.6 consecutive days of abstinence Standard Deviation 13.7	29 consecutive days of abstinence Standard Deviation 14.7	30 consecutive days of abstinence Standard Deviation 13

Adverse Events

Active Nicotine Patch and Contingency Management

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Nicotine Patch With no Contingency Management

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo Patch and Contingency Management

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Placebo Patch and no Contingency Management

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dana Cavallo, Assistant Professor

Yale University

Phone: 2039747607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Active Nicotine Patch and Contingency Management n=36 participants at risk Subjects in this group will receive Contingency Management and active nicotine patch Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day	Nicotine Patch With no Contingency Management n=37 participants at risk Subjects in this group will receive active nicotine patch without contingency management for abstinence Cognitive Behavioural Therapy: Weekly CBT for all subjects Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day	Placebo Patch and Contingency Management n=44 participants at risk Subjects in this group will receive a placebo transdermal patch and contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects Contingency Management: incentives given for abstinence based on urine analysis	Placebo Patch and no Contingency Management n=37 participants at risk Subjects in this group will receive a placebo patch and will not receive contingency management Cognitive Behavioural Therapy: Weekly CBT for all subjects
Gastrointestinal disorders Nausea	38.9% 14/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	29.7% 11/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	22.7% 10/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	37.8% 14/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
Gastrointestinal disorders Vomiting	22.2% 8/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	10.8% 4/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	11.4% 5/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	18.9% 7/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
Gastrointestinal disorders Abdominal Pain	25.0% 9/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	18.9% 7/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	15.9% 7/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	29.7% 11/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
General disorders Change in appetite	55.6% 20/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	54.1% 20/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	56.8% 25/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	59.5% 22/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
General disorders Headache	52.8% 19/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	64.9% 24/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	59.1% 26/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	59.5% 22/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
Nervous system disorders Dizziness	16.7% 6/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	29.7% 11/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	20.5% 9/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	37.8% 14/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
Eye disorders Blurred vision	16.7% 6/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	8.1% 3/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	11.4% 5/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	21.6% 8/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
Cardiac disorders Rapid Heartbeat	13.9% 5/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	16.2% 6/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	18.2% 8/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	18.9% 7/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
General disorders Fatigue	30.6% 11/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	35.1% 13/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	29.5% 13/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	45.9% 17/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
Social circumstances Nervousness	47.2% 17/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	43.2% 16/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	31.8% 14/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	37.8% 14/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
General disorders Insomnia	47.2% 17/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	35.1% 13/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	34.1% 15/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	29.7% 11/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
General disorders Sleepiness	33.3% 12/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	35.1% 13/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	45.5% 20/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	43.2% 16/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
Skin and subcutaneous tissue disorders Itching	38.9% 14/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	43.2% 16/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	25.0% 11/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	29.7% 11/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
Skin and subcutaneous tissue disorders Rash	25.0% 9/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	18.9% 7/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	11.4% 5/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	10.8% 4/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
Psychiatric disorders VIvid Dreams	41.7% 15/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	40.5% 15/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	34.1% 15/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	32.4% 12/37 • Adverse events were collected at baseline through duration of treatment-6 weeks
Respiratory, thoracic and mediastinal disorders Sweating	19.4% 7/36 • Adverse events were collected at baseline through duration of treatment-6 weeks	32.4% 12/37 • Adverse events were collected at baseline through duration of treatment-6 weeks	31.8% 14/44 • Adverse events were collected at baseline through duration of treatment-6 weeks	21.6% 8/37 • Adverse events were collected at baseline through duration of treatment-6 weeks