Combining a Smoke Ending Aid With Behavioral Treatment - 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006151
Recruitment Status : Completed
First Posted : August 9, 2000
Results First Posted : January 6, 2014
Last Update Posted : December 3, 2015
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Peter Gariti, University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Tobacco Use Disorder
Intervention: Behavioral: Behavioral Therapy

  Participant Flow

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
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   30   30   60 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 47.07  (11.4)   43.50  (12)   45.29  (11.7) 
[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

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
No text entered.

  More Information

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


Responsible Party: Peter Gariti, University of Pennsylvania Identifier: NCT00006151     History of Changes
Other Study ID Numbers: NIDA-11645-1
R01DA011645 ( U.S. NIH Grant/Contract )
First Submitted: August 8, 2000
First Posted: August 9, 2000
Results First Submitted: June 24, 2013
Results First Posted: January 6, 2014
Last Update Posted: December 3, 2015