NCT01085032

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2010

Completed
Last Updated

March 11, 2010

Status Verified

February 1, 2010

Enrollment Period

2.9 years

First QC Date

March 10, 2010

Last Update Submit

March 10, 2010

Conditions

Smoking Cessation

Keywords

Smoking CessationSubstance Withdrawal SyndromeDepression

Outcome Measures

Primary Outcomes (1)

  • Prolonged Abstinence

    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.

    7 weeks, 6 months and 12 months

Secondary Outcomes (3)

  • 7 day point prevalent abstinence

    7 weeks, 6 months and 12 months

  • Withdrawal symptoms

    7 weeks, 6 months, 12 months

  • Depressive symptomatology

    7 weeks, 6 months, 12 months

Study Arms (2)

Arm A

EXPERIMENTAL

Behavioral Counseling and Nicotine Patch

Drug: Transdermal Nicotine

Arm B

PLACEBO COMPARATOR

Behavioral counseling and placebo patch

Drug: Placebo nicotine patch

Interventions

Transdermal NicotineDRUG

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.

Arm A
Placebo nicotine patchDRUG

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.

Arm B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Four privately- or NGO-sponsored adult primary care clinics

Aleppo, Syria

Location

Related Publications (1)

  • Ward KD, Asfar T, Al Ali R, Rastam S, Weg MW, Eissenberg T, Maziak W. Randomized trial of the effectiveness of combined behavioral/pharmacological smoking cessation treatment in Syrian primary care clinics. Addiction. 2013 Feb;108(2):394-403. doi: 10.1111/j.1360-0443.2012.04048.x. Epub 2012 Nov 19.

    PMID: 22882805DERIVED

MeSH Terms

Conditions

Smoking CessationSubstance Withdrawal SyndromeDepression

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Kenneth D Ward, PhD

    University of Memphis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2010

First Posted

March 11, 2010

Study Start

August 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

March 11, 2010

Record last verified: 2010-02

Locations

SY(1)