Clinical Trials Logo
  1. Home
  2. Smoking
  3. NCT00633321

Study of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation

Smoking Clinical Trial

Official title:
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study of 100 or 250 μg of TA-NIC to Assess the Efficacy and Safety of the Vaccine as an Aid to Smoking Cessation

Clinical Trial Summary

Over 1 billion people worldwide smoke, resulting in an estimated 4 million deaths annually from smoking-related disease.1 Persistent and long-term smoking leads to an increased risk of cardiovascular damage, respiratory disease, and a higher incidence of a variety of cancers; but for smokers who can quit there is an immediate and significant beneficial impact on their health and life expectancy. Cigarette smoking remains the leading preventable cause of death in the United States (US), accounting for approximately 1 of every 5 deaths (438,000 people) each year.

This Phase 2 study will investigate the efficacy and tolerability of 2 doses of TA-NIC compared to placebo as an aid to smoking cessation in smokers who are motivated to quit.

Clinical Trial Description

This is a multicenter, double-blind, randomized, placebocontrolled, 3-arm, Phase 2 study evaluating the efficacy and safety of TA-NIC as an aid for smoking cessation in smokers motivated to quit within 12 weeks. At the start of the study, each subject will set a Target Quit Date, which must be within 12 weeks after first injection. Each subject will receive 7 injections (vaccinations) from Weeks 0 to 16. Subjects will be encouraged to follow a phased reduction in cigarette consumption leading up to the Target Quit Date. All vaccinated subjects will be offered a counseling session at each clinic visit and will be contacted by telephone at Weeks 1, 3, 5, 7, 9, 14, 18, and 21 to provide up to 10 minutes of support and counseling for their smoking cessation. Smoking cessation will be measured during a 4-week assessment period from Week 22 to Week 26. Smoking cessation will be defined as complete abstinence during this 4-week period. Subject follow-up will continue to Week 52. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00633321
Study type Interventional
Source Celtic Pharma Development Services
Contact
Status Completed
Phase Phase 2
Start date May 2007
Completion date February 2009
View Details
See also
  Status Clinical Trial Phase
Completed NCT03999411 - Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients Phase 4
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02649556 - A 26-week Extension of the ZRHR-ERS-09-US Study Evaluating Biological and Functional Changes in Healthy Smokers After Switching to THS 2.2 N/A
Completed NCT03901066 - Smoking Dependence and Periodontitis
Recruiting NCT05846841 - Personalized Tobacco Treatment in Primary Care (MOTIVATE) N/A
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Completed NCT03305978 - Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan. N/A
Completed NCT00000437 - Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone) Phase 4
Completed NCT06105424 - BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability N/A
Active, not recruiting NCT02752022 - Monitoring the Transition From Smoking to E-cigarettes
Completed NCT02912000 - TEACH: Technology Evaluation to Address Child Health N/A
Completed NCT02901171 - The Contribution of a Smartphone Application to Acceptance and Commitment Therapy Group Treatment for Smoking Cessation N/A
Completed NCT03206619 - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed NCT04340830 - The Effect of Smoking on Dimensional Changes of Free Gingival Graft Around Dental Implants N/A
Completed NCT02949648 - Electronic Cigarette Use and Quitting in Youth N/A
Completed NCT02945371 - Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life N/A
Completed NCT02246114 - Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women N/A
Completed NCT01954407 - Young Adults' Responses to Anti-smoking Messages N/A
Completed NCT03448900 - Intervention Study for Smoking Cessation in Spanish College Students N/A
Completed NCT01898507 - Nicotine Metabolism and Low Nicotine Cigarettes N/A