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Effects of Contingency Management and Nicotine Replacement Therapy on Youth Smoking

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Philip Morris USA, Inc.
Information provided by (Responsible Party):
Edythe London, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01359709
First received: May 19, 2011
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Cigarette Smoking Behavior
Drug: Nicotine polacrilex
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Contingency Management and Nicotine Replacement Therapy on Youth Smoking

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Smoking abstinence [ Time Frame: All five days (days 8 to 12) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Smoking craving (Change from baseline on day 12) [ Time Frame: Baseline (day 1), day 12 ] [ Designated as safety issue: No ]
    The measures used will be: Urge to Smoke (UTS)

  • Smoking withdrawal (Change from baseline on day 12) [ Time Frame: Baseline (day 1), day 12 ] [ Designated as safety issue: No ]
    The measures used will be: Minnesota Withdrawal Scale (MNWS)

  • Profile of mood states (Change from baseline on day 12) [ Time Frame: Baseline (day 1), day 12 ] [ Designated as safety issue: No ]
    The measures used will be Profile of Mood States (POMS)

  • Cigarette dependence (Change from baseline on day 12) [ Time Frame: Baseline (day 1), day 12 ] [ Designated as safety issue: No ]
    The measures used will be: Cigarette Dependence Scale (CDS-12)

  • Breath carbon monoxide (CO) levels (change from baseline on day 12) [ Time Frame: Baseline (day 1), day 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Contingency Management Drug: Nicotine polacrilex
Participants will apply Nicoderm (14 mg) patches everyday during this study.
Other Name: Nicoderm (14 mg)
Placebo Comparator: Noncontingent control Drug: Nicotine polacrilex
Participants will apply Nicoderm (14 mg) patches everyday during this study.
Other Name: Nicoderm (14 mg)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   13 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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.
  • have serious cardiovascular disease, including uncontrolled hypertension, coronary artery disease, serious cardiac arrhythmias, vasospastic disease, or angina, due to potential cardiovascular effects of nicotine, as determined via the baseline medical history and physical exam
  • have a medical condition that could be made worse by treatment with nicotine, including poorly controlled insulin dependent diabetes, uncontrolled hyperthyroidism, pheochromocytoma, severe oropharyngeal, esophageal, or peptic ulcer disease, or severe renal or hepatic impairment as determined via the baseline medical history and physical exam
  • have an allergy to adhesive tape or latex or serious dermatologic disease (excluding minor skin conditions such as mild eczema) due to potential for skin allergy to patch
  • if a participant's schedule do not permit to complete the 12-day study, and if he/she can not commit to arrive for the scheduled laboratory sessions.
  • have a known allergy to nicotine or any component of the nicotine patches
  • be receiving treatment with adenosine, bupropion or varenicline due to potential drug-drug interactions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01359709

Locations
United States, California
University California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Philip Morris USA, Inc.
Investigators
Principal Investigator: Edythe D London, Ph.D. University California, Los Angeles
  More Information

No publications provided

Responsible Party: Edythe London, Professor of Psychiatry and Biobehavioral Sciences and Molecular and Medical Pharmacology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01359709     History of Changes
Other Study ID Numbers: ASCC-CM-NRT
Study First Received: May 19, 2011
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014