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Nicotine Patch Trial in Syrian Primary Care Settings

This study has been completed.
Sponsor:
Information provided by:
University of Memphis
ClinicalTrials.gov Identifier:
NCT01085032
First received: March 10, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Smoking Cessation
Drug: Transdermal Nicotine
Drug: Placebo nicotine patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transdermal Nicotine Therapy as an Adjunct to Behavioral Smoking Cessation Counseling in Syrian Primary Care Settings

Resource links provided by NLM:


Further study details as provided by University of Memphis:

Primary Outcome Measures:
  • Prolonged Abstinence [ Time Frame: 7 weeks, 6 months and 12 months ] [ Designated as safety issue: No ]
    Self report and verified by exhaled CO levels of less than 10ppm. Prolonged abstinence will be defined as abstinence sustained after a 2 week grace period.


Secondary Outcome Measures:
  • 7 day point prevalent abstinence [ Time Frame: 7 weeks, 6 months and 12 months ] [ Designated as safety issue: No ]
    defined as non-smoking during the last 7 days and exhaled CO levels of <10ppm

  • Withdrawal symptoms [ Time Frame: 7 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
    Measured with the Withdrawal Symptoms List (Hughes et al., 1986, 1991).

  • Depressive symptomatology [ Time Frame: 7 weeks, 6 months, 12 months ] [ Designated as safety issue: No ]
    CES-D; Radloff, 1977


Enrollment: 269
Study Start Date: August 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Behavioral Counseling and Nicotine Patch
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.
Placebo Comparator: Arm B
Behavioral counseling and placebo patch
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.


Detailed Description:

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 behavioral counseling with and without transdermal nicotine therapy on long-term smoking cessation rates. The trial will be conducted at four primary care clinics in Aleppo, Syria that are sponsored by private or non governmental organizations. Clinic physicians will be trained to provide a brief assessment of each patient's smoking status and motivation to quit, and to refer appropriate patients to a cessation clinic within the primary care center. Eligible and interested smokers will be randomized to receive behavioral cessation counseling + nicotine patch or behavioral cessation counseling + placebo patch. Behavioral counseling will be delivered by a physician at each clinic.

After eligibility is determined and a description of the cessation program has been provided, written informed consent will be obtained. When literacy is a concern, the consent form will be read to the subjects who will then mark the form to indicate consent.

Participants will provide baseline demographic data (age, gender, ethnicity, residence, marital status, education, occupation, income), smoking related information (smoking history, level of dependence, interest in quitting, comorbidities), and complete additional questionnaires to assess quitting self-efficacy, stage of change, withdrawal symptoms, and depression/mood.

Participants will then be allocated to one of two treatment conditions (Arm A: behavioral counseling + nicotine patch vs. Arm B: behavioral counseling + placebo patch) using random permuted blocks, stratified according to primary care center and gender. Specific behavioral and pharmacological intervention procedures are as follows:

Participants in Arm A will receive active transdermal nicotine, and participants in Arm B will receive placebo patch. Transdermal nicotine replacement was selected as the pharmacologic agent of choice, based on its ease of use, acceptability to patients, favorable side effect and contraindications profile, and its well researched and documented efficacy (Fiore et al., 1994). Additionally, our pilot intervention work in Syria indicates a high degree of acceptability of the patch as a potential smoking cessation intervention (Asfar et al., 2005).

In accordance with clinical practice guidelines in the U.S. (Fiore et al., 2000), participants will receive six weeks of patch treatment, 24 hour dose, using a step-down algorithm. Participants who smoke greater than 10 cigarettes/day will be 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 will receive four weeks of 14 mg patch, followed by two weeks of 7 mg.

Subjects in both arms receive three brief face-to-face counseling sessions and five brief (approximately 10 minute) phone counseling calls. Session 1 occurs 3-4 days before the scheduled quit day and focuses on preparing to quit. Calls 1 and 2 occur the day before and the day after quit day, respectively, and focus on surviving the first few days as a non-smoker. Session 2 takes place 7 days after the quit day and emphasizes provision of social support, problem solving, and coping with withdrawal symptoms and negative emotions. The final session occurs 14 days after quit day and emphasizes relapse prevention and coping skills training. An additional three phone calls occur 10, 30, and 45 days after quit day and provide social support, check progress, and reinforce coping skills. Follow-up assessments occur at 7 weeks, 6 months, and 12 months post-cessation.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-65 years of age
  • smoking continuously for at least one year and smoking 5 cigarettes every day
  • Reside in the catchment area of one of the four primary care centers

Exclusion Criteria:

  • diagnosed with a generalized dermatology disease, liver failure, hyperthyroidism, or pheochromocytoma
  • current use of psychotropic drugs
  • past year history of drug or alcohol abuse, unstable cardiovascular, psychiatric, or debilitating diseases based on physician assessment.
  • currently pregnant, lactating, or intending to become pregnant in next 3 months
  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: NCT01085032

Locations
Syrian Arab Republic
Four privately- or NGO-sponsored adult primary care clinics
Aleppo, Syrian Arab Republic
Sponsors and Collaborators
University of Memphis
Investigators
Principal Investigator: Kenneth D Ward, PhD University of Memphis
  More Information

No publications provided by University of Memphis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kenneth D. Ward, PhD, University of Memphis
ClinicalTrials.gov Identifier: NCT01085032     History of Changes
Other Study ID Numbers: 1R01DA024876
Study First Received: March 10, 2010
Last Updated: March 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Memphis:
Smoking Cessation
Substance Withdrawal Syndrome
Depression

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 24, 2014