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A Smoking Cessation Treatment for Adult Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Andrea H. Weinberger, Yale University
ClinicalTrials.gov Identifier:
NCT01422239
First received: August 19, 2011
Last updated: June 6, 2013
Last verified: June 2013
Results First Received: March 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Nicotine Dependence
Interventions: Behavioral: Tailored treatment
Behavioral: Standard Treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment of participants began in August of 2011 an ended in September 2012. Recruitment methods included radio advertisements, ClinicalTrials.gov, Craig’s List postings, flyers, and referrals from research colleagues in the Department of Psychiatry

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
28 adults signed the consent form and 20 adults were randomized and began the study. The 8 participants who completed the consent procedures but were not randomized were either not eligible (drug use, n=3; psychiatric diagnoses, n=2; low smoking, n=1) or did not attend the first study appointment and did not respond to attempts to contact (n=2).

Reporting Groups
  Description
Tailored Behavioral Counseling The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session, coping with withdrawal symptoms in the third session, and on coping with triggers and withdrawal in the forth session using the Mayo Clinic's smoking cessation manual. The focus of sessions 5-7 will be the three perceive risks of quitting that were not covered during the first three session (i.e., the three least highly endorsed risks). Session 8 will cover maintenance of smoking abstinence using the Mayo Clinic manual.
Standard Behavioral Counseling The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's smoking cessation manual. All of the material for sessions 4-8 for the standard behavioral counseling condition will cover topics from the Mayo Clinic's smoking cessation manual - Session 4: coping with triggers to smoke and nicotine withdrawal, Session 5: Stress Management, Session 6: Time Management and Self-Image, Session 7: Communication Skills and Wellness, Session 8: Focusing on the Future (maintenance of smoking abstinence).

Participant Flow:   Overall Study
    Tailored Behavioral Counseling     Standard Behavioral Counseling  
STARTED     14     6  
COMPLETED     10     3  
NOT COMPLETED     4     3  
Lost to Follow-up                 4                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tailored Behavioral Counseling The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's "Smoke Free and Living It" manual. The last 5 counseling sessions will be based on perceived risks of quitting.
Standard Behavioral Counseling The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's "Smoke Free and Living It" manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual.
Total Total of all reporting groups

Baseline Measures
    Tailored Behavioral Counseling     Standard Behavioral Counseling     Total  
Number of Participants  
[units: participants]
  14     6     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     6     20  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  43.9  ± 8.4     45.8  ± 13.3     44.5  ± 9.8  
Gender  
[units: participants]
     
Female     14     6     20  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     14     6     20  



  Outcome Measures
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1.  Primary:   Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels   [ Time Frame: Up to 8 weeks ]

2.  Secondary:   Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels   [ Time Frame: 12 weeks ]

3.  Secondary:   Change in Smoking From Baseline to the Followup Assessment (Week 12)   [ Time Frame: Week 0 (baseline), Week 12 (one month followup) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size, half to two-thirds of participants dropped out of the active study phase, half to one quarter did not complete the one month follow up. Female participants only results can not be generalized to men.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrea Weinberger, Ph.D.
Organization: Yale University School of Medicine
phone: 203-974-7598
e-mail: andrea.weinberger@yale.edu


No publications provided


Responsible Party: Andrea H. Weinberger, Yale University
ClinicalTrials.gov Identifier: NCT01422239     History of Changes
Other Study ID Numbers: AHW-WHRY-526
Study First Received: August 19, 2011
Results First Received: March 19, 2013
Last Updated: June 6, 2013
Health Authority: United States: Yale Human Investigation Committee