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Nicotine Patch Trial in Syrian Primary Care Settings

NCT01085032 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2010-03-11

No results posted yet for this study

Summary

The study is a two-arm, parallel group, randomized, placebo-controlled, double blind trial, conducted at four primary health care centers in Aleppo, Syria, to test the efficacy of transdermal nicotine patch therapy vs. placebo patch therapy, when delivered with behavioral counseling, on smoking cessation rates.

Conditions

  • Smoking Cessation

Interventions

DRUG

Transdermal Nicotine

Subjects in the experimental group receive six weeks of nicotine patch treatment, 24 hour dose, using a step-down algorithm. Participants who smoke greater than 10 cigarettes/day receive two weeks of 21 mg patch, followed by two weeks of 14 mg patch, and then two weeks of 7 mg patch. Participants who smoke 5-9 cigarettes per day receive four weeks of 14 mg patch, followed by two weeks of 7 mg.

DRUG

Placebo nicotine patch

Subjects in the placebo condition receive an inert placebo patch matched for size, shape, color, and packaging. The same step-down dosing algorithm as in the experimental condition is used.

Sponsors & Collaborators

  • University of Memphis

    lead OTHER

Principal Investigators

  • Kenneth D Ward, PhD · University of Memphis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01085032 on ClinicalTrials.gov