Nicotine Delivery Systems: Research & Treatment (NDS)

This study has been terminated.
(Common comorbidities of Veterans precluded sufficient recruitment and enrollment.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00108342
First received: April 14, 2005
Last updated: June 2, 2014
Last verified: June 2014
Results First Received: December 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Smoking
Interventions: Drug: Nicotine gum - 2 mg and 4 mg
Drug: Nicotine lozenges - 2 mg and 4 mg
Drug: Nicotine inhaler (4 mg yield) - low and high "dosage" by frequency of puffing
Other: Computer learning

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
25 enrollees gave their signed consent and were then screened for participation; a total of 17 participated in testing.

Reporting Groups
  Description
NRT Sampling

Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)

Nicotine gum - 2 mg and 4 mg

Nicotine lozenges - 2 mg and 4 mg

Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)

NRT Computer Learning Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only

Participant Flow:   Overall Study
    NRT Sampling     NRT Computer Learning  
STARTED     8     9  
COMPLETED     7     9  
NOT COMPLETED     1     0  



  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
NRT Sampling

Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)

Nicotine gum - 2 mg and 4 mg

Nicotine lozenges - 2 mg and 4 mg

Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)

NRT Computer Learning Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
Total Total of all reporting groups

Baseline Measures
    NRT Sampling     NRT Computer Learning     Total  
Number of Participants  
[units: participants]
  8     9     17  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     8     9     17  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     0     1  
Male     7     9     16  
Region of Enrollment  
[units: participants]
     
United States     8     9     17  



  Outcome Measures

1.  Primary:   Quit Attempts, Use of NRTs, Preference Among NRTs   [ Time Frame: At testing, at follow-up ]


  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
Limitations of the study: early termination of the study occurred due to widespread comorbidities precluding recruitment and enrollment of Veterans in this NRT trial. Specifically, the sample size was too small for any data analyses.


  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: Nina G. Schneider, Ph.D., Principle Investigator
Organization: Department of Veterans Affairs - VAGLA
phone: 310-268-3059
e-mail: ngs@ucla.edu


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108342     History of Changes
Obsolete Identifiers: NCT00876239
Other Study ID Numbers: NEUA-015-07S
Study First Received: April 14, 2005
Results First Received: December 19, 2013
Last Updated: June 2, 2014
Health Authority: United States: Federal Government