Effects of Contingency Management and Nicotine Replacement Therapy on Youth Smoking

NCT01359709 | Completed Phase 1

• 1 other identifier: ASCC-CM-NRT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Cigarette smoking is an important public health concern, and it is most often initiated in adolescence. Despite substantial research on smoking cessation in adults, however, relatively little effort has focused on therapeutic approaches to reduce adolescent smoking. Behavioral interventions, such as contingency management (CM), and pharmacotherapies, such as nicotine replacement therapy (NRT), each have some efficacy in reducing adolescent smoking, and in adults, combination of behavioral and pharmacological approaches is more effective in reducing smoking than either one alone. Little is known about combining these therapeutic approaches in adolescent smokers, and research in this area has been hindered, in part, by the expense and complexity of large-scale clinical trials of the combined treatments and the relative dearth of a cost-effective laboratory procedure. Developing and validating a laboratory model to evaluate the combined effects of CM and pharmacological adjuncts for adolescent smoking is important because such studies can be conducted more rapidly and efficiently, and could provide information on the optimal conditions (e.g., dose) under which pharmacotherapies might augment the positive effects of CM. The investigators propose to conduct a randomized, placebo-controlled, double-blind, between-groups, 2-week laboratory study. Participants will be randomly assigned to one of the following four groups: CM+nicotine patches, CM+placebo patches, noncontingent control (NC)+nicotine patches and NC+placebo patches. Fifteen participants will be enrolled in each of the four groups, totaling 60 participants. On day 1, participants will arrive to the laboratory for a 1-h session. During this session, breath carbon monoxide (CO) levels, saliva or urinary cotinine levels will be evaluated. Participants will also complete questionnaires on craving, withdrawal and cigarette dependence. Participants will then receive seven patches, to wear for seven days, one patch daily. Five sessions during the days 8 to 12 will serve as CM or noncontingent sessions, and participants will continue wearing patch daily. On these sessions, breath CO levels will be evaluated, and participants will have opportunity to receive payments based on their CO levels, according to the group assignment. If successful, the proposed study will provide a human laboratory model for use in studies of the combined CM and pharmacological approaches for modifying adolescent smoking behavior.

Conditions

Cigarette Smoking Behavior

Outcome Measures

Primary Outcomes (1)

• Smoking abstinence

  Percentage of participants continuously abstinent (breath carbon monoxide ≤ 6 ppm) across all five laboratory sessions in the second week (days 8 to 12) in the contingency management + nicotine replacement therapy (CM+NRT) group versus noncontingent control + nicotine replacement therapy (NC+NRT) group.

  All five days (days 8 to 12)

Secondary Outcomes (5)

• Smoking craving (Change from baseline on day 12)

  Baseline (day 1), day 12

• Smoking withdrawal (Change from baseline on day 12)

  Baseline (day 1), day 12

• Profile of mood states (Change from baseline on day 12)

  Baseline (day 1), day 12

• Cigarette dependence (Change from baseline on day 12)

  Baseline (day 1), day 12

• Breath carbon monoxide (CO) levels (change from baseline on day 12)

  Baseline (day 1), day 12

Study Arms (2)

Contingency Management

EXPERIMENTAL

Drug: Nicotine polacrilex

Noncontingent control

PLACEBO COMPARATOR

Drug: Nicotine polacrilex

Interventions

Nicotine polacrilex DRUG

Participants will apply Nicoderm (14 mg) patches everyday during this study.

Also known as: Nicoderm (14 mg)

Contingency Management; Noncontingent control

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• ages 13-21, inclusive
• English-speaking
• Report daily smoking 10 or less cigarettes
• have smoked for at least 6 months
• Expired breath carbon monoxide (CO) levels 6 or more and Urine cotinine levels \>100 ng/ml during intake screening
• Sexually active female subjects will be considered eligible for participation only if they are using a double barrier method of birth control (e.g., diaphragm, intrauterine device, or condom along with spermicide) or hormonal contraceptives (such as prescribed "birth control pills", injections, or a prescribed birth control implant). Such birth control methods should have been used for one month before beginning participation in the research study and continue throughout the study.
• Participants' willingness to quit

You may not qualify if:

• Pregnancy: We will administer a pregnancy test at each study visit. Female participants who are pregnant will not qualify for study and if found pregnant during the study, they will be excluded from further participation.
• Medications and Substances:
• Evidence (urine analysis) or self-reported current use of psychotropic medications or substances other than:
• Marijuana
• Alcohol
• Nicotine
• Language: Lack of fluency in English Note: If a participant is not a fluent English speaker, the language barrier will interfere with performance of psychological tests and completing questionnaires used in the study. The consent form, all questionnaires, and instructions will be given in English.
• Psychiatric Disease:
• Current or lifetime diagnosis of an Axis I disorder (according to DSM-IV criteria), except for the following:
• Current or lifetime Marijuana Abuse or dependence
• Current or lifetime Nicotine Dependence
• Current or lifetime Alcohol Abuse or dependence
• ADHD or conduct disorders
• Neurological:
• Neurological status that is not within normal limits as determined by a physician and as indicated in self-report.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Philip Morris USA, Inc.: collaborator

Study Sites (1)

University California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Edythe D London, Ph.D.

  University California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Biobehavioral Sciences and Molecular and Medical Pharmacology

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 25, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

US (1)