Combining a Smoke Ending Aid With Behavioral Treatment - 1

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Peter Gariti, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00006151
First received: August 8, 2000
Last updated: November 15, 2013
Last verified: November 2013
Results First Received: June 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Intervention: Behavioral: Behavioral Therapy

  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
Participants were recruited to a university based center for the study of addictions in 2002.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study used a real world design meaning that participants were randomized on the same day as their study eligibility evaluation.

Reporting Groups
  Description
Accu Drops (AD&C) The experimental group (N=30) will be prescribed active Accu Drops (AD&C)
Placebo (PD&C) The control condition (N=30) will be prescribed placebo Accu Drops (PD&C)

Participant Flow:   Overall Study
    Accu Drops (AD&C)     Placebo (PD&C)  
STARTED     30     30  
COMPLETED     17     16  
NOT COMPLETED     13     14  



  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.
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Reporting Groups
  Description
Accu Drop Plus Counseling Active product and systematic cigarette tapering plus counseling.
Placebo Accu Drop Plus Counseling Placebo product and systematic cigarette tapering plus counseling
Total Total of all reporting groups

Baseline Measures
    Accu Drop Plus Counseling     Placebo Accu Drop Plus Counseling     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     30     30     60  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  47.07  ± 11.4     43.50  ± 12     45.29  ± 11.7  
Gender  
[units: participants]
     
Female     17     20     37  
Male     13     10     23  
Region of Enrollment  
[units: participants]
     
United States     30     30     60  



  Outcome Measures

1.  Primary:   Abstinence Rate   [ Time Frame: 1 year ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter Gariti
Organization: University of Pennsylvania
e-mail: gar1iti@mail.med.upenn.edu


Publications:

Responsible Party: Peter Gariti, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00006151     History of Changes
Other Study ID Numbers: NIDA-11645-1, R01DA011645
Study First Received: August 8, 2000
Results First Received: June 24, 2013
Last Updated: November 15, 2013
Health Authority: United States: Federal Government