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Acceptability of Less Harmful Alternatives to Cigarettes

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ClinicalTrials.gov Identifier: NCT00957424
Recruitment Status : Completed
First Posted : August 12, 2009
Results First Posted : December 14, 2016
Last Update Posted : February 7, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions Bladder Cancer
Cervical Cancer
Esophageal Cancer
Gastric Cancer
Head and Neck Cancer
Kidney Cancer
Leukemia
Liver Cancer
Lung Cancer
Pancreatic Cancer
Tobacco Use Disorder
Interventions Behavioral: telephone-based intervention
Drug: nicotine replacement therapy
Other: informational intervention
Other: internet-based intervention
Other: questionnaire administration
Enrollment 67
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Noncombusted Nicotine Product With Informational Intervention
Hide Arm/Group Description Single-armed study
Period Title: Overall Study
Started 67
Follow-up #1 59
Follow-up #2 50
Completed 44
Not Completed 23
Reason Not Completed
Lost to Follow-up             19
Protocol Violation             3
Withdrawal by Subject             1
Arm/Group Title Overall
Hide Arm/Group Description Single-armed study
Overall Number of Baseline Participants 67
Hide Baseline Analysis Population Description
Current smokers, aged 18+, smoke at least 10 cigarettes per day, not planning to quit smoking in the next 30 days
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 67 participants
46.7  (9.59)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
Female
35
  52.2%
Male
32
  47.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
Hispanic or Latino
5
   7.5%
Not Hispanic or Latino
61
  91.0%
Unknown or Not Reported
1
   1.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
19
  28.4%
White
42
  62.7%
More than one race
5
   7.5%
Unknown or Not Reported
1
   1.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 67 participants
67
1.Primary Outcome
Title Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall
Hide Arm/Group Description:
Single-armed study
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: participants
7
2.Primary Outcome
Title Number of Participants Willing to Try HRPs
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall
Hide Arm/Group Description:
Single-armed study
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: participants
60
3.Primary Outcome
Title Number of Participants That Completed 1-week Trial
Hide Description [Not Specified]
Time Frame One week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Overall
Hide Arm/Group Description:
Single-armed study
Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: participants
50
4.Primary Outcome
Title Number of Participants Willing to Continue With Preferred HRP
Hide Description [Not Specified]
Time Frame 1 week follow up
Hide Outcome Measure Data
Hide Analysis Population Description
Those who completed one-week multiple product sampling
Arm/Group Title Overall
Hide Arm/Group Description:
Single-armed study
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: participants
49
Time Frame Collected over 2 weeks while participants were using tobacco products
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall
Hide Arm/Group Description Single-armed study
All-Cause Mortality
Overall
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Overall
Affected / at Risk (%)
Total   0/59 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Overall
Affected / at Risk (%)
Total   0/59 (0.00%) 
About 1/3 of initial participants did not complete this study. The limited number of participants precludes identifying demographic predictors of willingness or patterns of substitution. Single armed study lacks comparison group.
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: Richard O'Connor
Organization: Roswell Park Cancer Institute
Phone: 716-845-4517
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00957424     History of Changes
Other Study ID Numbers: CDR0000648665
P30CA016056 ( U.S. NIH Grant/Contract )
RPCI-I-118207
First Submitted: August 11, 2009
First Posted: August 12, 2009
Results First Submitted: October 19, 2016
Results First Posted: December 14, 2016
Last Update Posted: February 7, 2017