Enhancing a High School Based Smoking Cessation Program

Yale University

Status: Completed

Conditions: Nicotine Dependence

Treatments: Drug: Nicotine Transdermal Patch; Behavioral: Cognitive Behavioural Therapy; Behavioral: Contingency Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01145001

P50DA009241-17 (U.S. NIH Grant/Contract)

020718574

Details and patient eligibility

About

The purpose of this study is to examine the the efficacy of adjunctive nicotine replacement therapy when used in combination with the contingency management (CM) + cognitive behavioral therapy intervention. Subjects will be randomly assigned to receive either a nicotine transdermal patch or a placebo patch as well as being randomly assigned to receive either CM or no CM; all subjects will receive cognitive behavioral therapy. We hypothesize that that subjects receiving both active nicotine patch and CM will have higher rates of abstinence from tobacco than subjects in the other groups.

Enrollment: 154 patients

Sex: All

Ages: 14 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• High School aged
• Desire to quit smoking
• Smoking >5 cigarettes per day
• Able to read and write in English

Exclusion criteria

• Current dependence on other substances
• Medical conditions that would contraindicate the use of a nicotine patch

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

154 participants in 4 patient groups, including a placebo group

Active Nicotine Patch and Contingency Management

Active Comparator group

Description:

Subjects in this group will receive Contingency Management and active nicotine patch

Treatment:

Behavioral: Contingency Management

Drug: Nicotine Transdermal Patch

Behavioral: Cognitive Behavioural Therapy

Nicotine Patch with no Contingency Management

Active Comparator group

Description:

Subjects in this group will receive active nicotine patch without contingency management for abstinence

Treatment:

Drug: Nicotine Transdermal Patch

Behavioral: Cognitive Behavioural Therapy

Placebo patch and Contingency Management

Placebo Comparator group

Description:

Subjects in this group will receive a placebo transdermal patch and contingency management

Treatment:

Behavioral: Contingency Management

Behavioral: Cognitive Behavioural Therapy

Placebo Patch and no Contingency Management

Placebo Comparator group

Description:

Subjects in this group will receive a placebo patch and will not receive contingency management

Treatment:

Behavioral: Cognitive Behavioural Therapy