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Persistence-Targeted Smoking Cessation (PTSC)

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ClinicalTrials.gov Identifier: NCT01654107
Recruitment Status : Completed
First Posted : July 31, 2012
Results First Posted : September 16, 2015
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Tobacco Use Disorder
Interventions Behavioral: Persistence Targeted Smoking Cessation
Behavioral: Clearing The Air
Drug: Nicotine lozenge
Enrollment 58
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Persistence Targeted Smoking Cessation Clearing The Air
Hide Arm/Group Description

Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge

Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")

Nicotine lozenge: 12-weeks 4mg nicotine lozenge

Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge

Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air

Nicotine lozenge: 12-weeks 4mg nicotine lozenge

Period Title: Overall Study
Started 28 30
Completed 25 22
Not Completed 3 8
Arm/Group Title Persistence Targeted Smoking Cessation Clearing The Air Total
Hide Arm/Group Description

Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge

Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")

Nicotine lozenge: 12-weeks 4mg nicotine lozenge

Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge

Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air

Nicotine lozenge: 12-weeks 4mg nicotine lozenge

Total of all reporting groups
Overall Number of Baseline Participants 28 30 58
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 30 participants 58 participants
47.82  (10.205) 48.93  (8.574) 48.40  (9.330)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 30 participants 58 participants
Female
17
  60.7%
16
  53.3%
33
  56.9%
Male
11
  39.3%
14
  46.7%
25
  43.1%
1.Primary Outcome
Title 7-day Point Prevalence Abstinence
Hide Description 3-months after the Quit Date
Time Frame 3-months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Persistence Targeted Smoking Cessation Clearing The Air
Hide Arm/Group Description:

Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge

Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")

Nicotine lozenge: 12-weeks 4mg nicotine lozenge

Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge

Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air

Nicotine lozenge: 12-weeks 4mg nicotine lozenge

Overall Number of Participants Analyzed 25 28
Measure Type: Number
Unit of Measure: participants
4 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Persistence Targeted Smoking Cessation Clearing The Air
Hide Arm/Group Description

Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge

Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")

Nicotine lozenge: 12-weeks 4mg nicotine lozenge

Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge

Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air

Nicotine lozenge: 12-weeks 4mg nicotine lozenge

All-Cause Mortality
Persistence Targeted Smoking Cessation Clearing The Air
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Persistence Targeted Smoking Cessation Clearing The Air
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Persistence Targeted Smoking Cessation Clearing The Air
Affected / at Risk (%) Affected / at Risk (%)
Total   19/28 (67.86%)   13/30 (43.33%) 
Cardiac disorders     
Heart flutter  1/28 (3.57%)  0/30 (0.00%) 
Gastrointestinal disorders     
Upset stomach  3/28 (10.71%)  1/30 (3.33%) 
Heartburn  2/28 (7.14%)  0/30 (0.00%) 
Diarrhea  1/28 (3.57%)  1/30 (3.33%) 
Nausea  3/28 (10.71%)  3/30 (10.00%) 
Decreased appetite  1/28 (3.57%)  0/30 (0.00%) 
Vomiting  2/28 (7.14%)  0/30 (0.00%) 
Constipation  1/28 (3.57%)  0/30 (0.00%) 
Irregular Bowel Movement  1/28 (3.57%)  0/30 (0.00%) 
Gas  0/28 (0.00%)  1/30 (3.33%) 
Increased appetite  0/28 (0.00%)  1/30 (3.33%) 
General disorders     
Dry Mouth  1/28 (3.57%)  2/30 (6.67%) 
Throat irritation  8/28 (28.57%)  4/30 (13.33%) 
Hiccups  4/28 (14.29%)  0/30 (0.00%) 
Coughing  2/28 (7.14%)  1/30 (3.33%) 
Sore throat  2/28 (7.14%)  1/30 (3.33%) 
Tooth ache  1/28 (3.57%)  0/30 (0.00%) 
Sweating  0/28 (0.00%)  1/30 (3.33%) 
Nose flaring  0/28 (0.00%)  1/30 (3.33%) 
Burning sensation in cheek area  0/28 (0.00%)  1/30 (3.33%) 
Sore gums  0/28 (0.00%)  1/30 (3.33%) 
Canker sore  0/28 (0.00%)  1/30 (3.33%) 
Burning pepper taste  0/28 (0.00%)  1/30 (3.33%) 
Immune system disorders     
Cold symptoms  1/28 (3.57%)  2/30 (6.67%) 
Nasal congestion  1/28 (3.57%)  0/30 (0.00%) 
Nervous system disorders     
Dizziness  1/28 (3.57%)  1/30 (3.33%) 
Migraine  1/28 (3.57%)  1/30 (3.33%) 
Headache  1/28 (3.57%)  1/30 (3.33%) 
Fibromyalgia pain worsening  0/28 (0.00%)  1/30 (3.33%) 
Psychiatric disorders     
Insomnia  4/28 (14.29%)  0/30 (0.00%) 
Irritability  0/28 (0.00%)  2/30 (6.67%) 
Poor concentration/forgetfulness  0/28 (0.00%)  1/30 (3.33%) 
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: Marc L. Steinberg, Ph.D.
Organization: Rutgers Robert Wood Johnson Medical School
Phone: 7322354341
Responsible Party: Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01654107     History of Changes
Other Study ID Numbers: 0220110199
R34DA030652 ( U.S. NIH Grant/Contract )
First Submitted: July 19, 2012
First Posted: July 31, 2012
Results First Submitted: August 17, 2015
Results First Posted: September 16, 2015
Last Update Posted: August 21, 2017