Clinical Trials Logo
  1. Home
  2. Tobacco Use Disorder
  3. NCT01654107
  4. Details
NCT01654107 Clinical Trial

Persistence-Targeted Smoking Cessation

Tobacco Use Disorder Clinical Trial

— PTSC  

Official title:
Persistence-Targeted Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01654107
Other study ID # 0220110199
Secondary ID R34DA030652
Status Completed
Phase Phase 1
First received July 19, 2012
Last updated August 17, 2015
Start date July 2012
Est. completion date September 2014

Study information
Verified date July 2015
Source Rutgers, The State University of New Jersey
Contact n/a
Is FDA regulated No
Health authority United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The investigators propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. The investigators will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence).

Description:

In this Stage I Behavioral & Integrative Treatment Development (R34) project, we propose to develop a theory-based smoking cessation intervention (called Persistence-targeted smoking cessation; PTSC). PTSC includes 8 weekly individual counseling sessions and use of nicotine lozenge for 12 weeks. We will test the feasibility and preliminary efficacy of the intervention (i.e., cigarettes per day and prolonged abstinence). We hope to develop a feasible psychosocial treatment for use in a later randomized controlled trial.

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Must be between 18 - 64 years old

- Must smoke at least 10 cigarettes per day for past 6-months

- Expired breath carbon monoxide (CO) > 7

- Must have a working cellular phone

Exclusion Criteria:

- Must not be currently receiving tobacco dependence treatment counseling

- Must not currently be taking varenicline, bupropion, or any nicotine preparations (gum, lozenge, patch, spray, inhaler)

- Must have no contraindications to using nicotine lozenge

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Persistence Targeted Smoking Cessation
8-weeks of smoking cessation counseling ("Persistence Targeted Smoking Cessation")
• Clearing The Air
8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
Drug:
• Nicotine lozenge
12-weeks 4mg nicotine lozenge

Locations
Country Name City State
United States Rutgers Robert Wood Johnson Medical School New Brunswick New Jersey

Sponsors (2)
Lead Sponsor Collaborator
Rutgers, The State University of New Jersey National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 7-day Point Prevalence Abstinence 3-months after the Quit Date 3-months No
See also
  Status Clinical Trial Phase
Withdrawn NCT02432066 - Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions Phase 2
Completed NCT03960138 - Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Completed NCT04646668 - Comparative Abuse Liability Among African American and White Smokers N/A
Completed NCT02560324 - Effect of Ramelteon on Smoking Abstinence Phase 2
Completed NCT02347605 - Medicinal Nicotine for Preventing Cue Induced Craving N/A
Completed NCT01442753 - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth N/A
Completed NCT01428310 - Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke Phase 1
Completed NCT01625767 - Tobacco Approach Avoidance Training for Adolescent Smokers-1 Phase 2
Terminated NCT01800500 - Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers N/A
Completed NCT01570595 - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV Phase 1/Phase 2
Active, not recruiting NCT01539525 - Screening to Augment Referral to Treatment- Project START Phase 2
Completed NCT00967005 - N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers Phase 2
Completed NCT01337817 - A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers Phase 1
Active, not recruiting NCT00751660 - Screening Methods in Finding Lung Cancer Early in Current or Former Smokers N/A
Completed NCT00790569 - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking N/A
Completed NCT00664261 - Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking N/A
Completed NCT00134927 - A Survey on Consumer Use of Over-the-Counter (OTC) Nicotine Patches N/A
Completed NCT00158145 - Assessing the Variability Over Time of Tobacco Carcinogen Biomarkers in Smokers - 2 Phase 2
Completed NCT00158158 - Effectiveness of Reducing Smoking in Facilitating Smoking Cessation in Adolescents - 2 Phase 2/Phase 3