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Tobacco Intervention in Primary Care Treatment Opportunities for Providers (TipTop)

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ClinicalTrials.gov Identifier: NCT02096029
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Matthew Carpenter, Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Smoking
Smoking Cessation
Interventions Other: Nicotine Replacement Therapy (NRT) Sampling
Behavioral: Ask, Advise, Refer (physician brief advice)
Enrollment 1278
Recruitment Details  
Pre-assignment Details

Of 1,278 Enrolled:

32 Individuals later found to be ineligible

1 person missing contact info

1,245 = Final Intent to Treat Sample

Arm/Group Title Standard Care Standard Care + Nicotine Replacement Therapy (NRT)
Hide Arm/Group Description Ask, Advise, Refer (physician brief advice)

2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice)

Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch

Period Title: Overall Study
Started 652 593
Completed 652 593
Not Completed 0 0
Arm/Group Title Standard Care Standard Care + Nicotine Replacement Therapy (NRT) Total
Hide Arm/Group Description Ask, Advise, Refer (physician brief advice)

2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice)

Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch

Total of all reporting groups
Overall Number of Baseline Participants 652 593 1245
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 652 participants 593 participants 1245 participants
51.0  (13.6) 50.4  (13.4) 50.7  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 652 participants 593 participants 1245 participants
Female
365
  56.0%
391
  65.9%
756
  60.7%
Male
287
  44.0%
202
  34.1%
489
  39.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White or African American Number Analyzed 652 participants 593 participants 1245 participants
White
346
  53.1%
433
  73.0%
779
  62.6%
African American
306
  46.9%
160
  27.0%
466
  37.4%
Heaviness of Smoking Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 652 participants 593 participants 1245 participants
2.6  (1.6) 2.8  (1.4) 2.7  (1.5)
[1]
Measure Description: HSI: Heaviness of Smoking Index (0-6 scale), where 6 indicates the highest ("worst") Heaviness of Smoking.
Motivation to Quit   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 652 participants 593 participants 1245 participants
6.2  (3.7) 6.4  (3.6) 6.3  (3.65)
[1]
Measure Description: Motivation to quit smoking in next month (0-10), where 0 indicates no desire to quit within the next month and 10 indicates full intent to quit within the next month.
1.Primary Outcome
Title Percentage of Participants With 7-Day Self-Reported Point Prevalence Abstinence
Hide Description [Not Specified]
Time Frame From study enrollment through end of six-month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care + Nicotine Replacement Therapy (NRT) Standard Care
Hide Arm/Group Description:

2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice)

Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch

Ask, Advise, Refer (physician brief advice)
Overall Number of Participants Analyzed 593 652
Measure Type: Number
Unit of Measure: percentage of participants
12 8
2.Secondary Outcome
Title Any Self-defined Attempt to Stop Smoking Cigarettes
Hide Description [Not Specified]
Time Frame From study enrollment through end of six-month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care + Nicotine Replacement Therapy (NRT) Standard Care
Hide Arm/Group Description:

2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice)

Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch

Ask, Advise, Refer (physician brief advice)
Overall Number of Participants Analyzed 593 652
Measure Type: Number
Unit of Measure: percentage of participants
48 45
3.Secondary Outcome
Title Use of Any Smoking Cessation Medication
Hide Description [Not Specified]
Time Frame From study enrollment through end of six-month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Care + Nicotine Replacement Therapy (NRT) Standard Care
Hide Arm/Group Description:

2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice)

Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch

Ask, Advise, Refer (physician brief advice)
Overall Number of Participants Analyzed 593 652
Measure Type: Number
Unit of Measure: percentage of participants
25 14
Time Frame Study consists of 3 follow-up phone calls at 1 month, 3 months, and 6 months post-baseline clinic visit. Adverse events are asked systematically of both groups, at all three follow-up calls.
Adverse Event Reporting Description Adverse Events were monitored/assessed without regard to a specific Adverse Event Term.
 
Arm/Group Title Standard Care Standard Care + Nicotine Replacement Therapy (NRT)
Hide Arm/Group Description Ask, Advise, Refer (physician brief advice)

2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch + Ask, Advise, Refer (physician brief advice)

Nicotine Replacement Therapy (NRT) Sampling: 2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch

All-Cause Mortality
Standard Care Standard Care + Nicotine Replacement Therapy (NRT)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/652 (0.46%)      1/593 (0.17%)    
Hide Serious Adverse Events
Standard Care Standard Care + Nicotine Replacement Therapy (NRT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/652 (3.07%)      9/593 (1.52%)    
Surgical and medical procedures     
Surgical and medical procedures   20/652 (3.07%)  22 9/593 (1.52%)  9
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Care Standard Care + Nicotine Replacement Therapy (NRT)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   289/652 (44.33%)      276/593 (46.54%)    
General disorders     
Other   289/652 (44.33%)  625 276/593 (46.54%)  596
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Amy Boatright, Program Coordinator
Organization: Medical University of South Carolina
Phone: 843-876-2440
EMail: boatrigh@musc.edu
Layout table for additonal information
Responsible Party: Matthew Carpenter, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02096029    
Other Study ID Numbers: Pro00019201
2R01DA021619 ( U.S. NIH Grant/Contract )
First Submitted: March 21, 2014
First Posted: March 26, 2014
Results First Submitted: June 13, 2019
Results First Posted: August 7, 2019
Last Update Posted: August 7, 2019