Nicotine Patch Trial in Syrian Primary Care Settings
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): Transdermal Nicotine; Placebo nicotine patch
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking Cessation; Substance Withdrawal Syndrome; Depression