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NCT01359709 · ClinicalTrials.gov registry record · Phase 1
Effects of Contingency Management and Nicotine Replacement Therapy on Youth Smoking
A Phase 1 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT01359709 is a Phase 1 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 60 participants.
The verdict
NCT01359709, a Phase 1 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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 d
Interventions
- DRUG Nicotine polacrilex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01359709
The ClinicalTrials.gov registry entry for NCT01359709 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nicotine polacrilex is the first listed.
NCT01359709 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01359709 about?
NCT01359709 is a clinical study titled "Effects of Contingency Management and Nicotine Replacement Therapy on Youth Smoking". 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 a...
What is the current status of trial NCT01359709?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2011-06. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01359709?
The interventions under investigation include: Nicotine polacrilex (DRUG).
Who is sponsoring clinical trial NCT01359709?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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