Tobacco Cessation: Treatment Delivery and Predictors of Outcome
- The success rate for those who attempt to quit using tobacco products is only about 5 percent. Many people who try to quit do so without seeking professional help. Several kinds of nicotine replacement therapy (NRT) are available without a prescription. However, prescription drugs and mental health counseling can also help people stop using tobacco. Combining NRT and/or medication with counseling can increase success rates. Researchers want to study what kinds of tobacco cessation treatments are most successful. This may help develop better treatments and determine who will respond best to them.
- To provide treatment for tobacco use.
- To identify factors that affect how well people respond to treatment.
- Individuals at least 18 years of age who are trying to stop using tobacco products.
- This study will last up to 1 year. Treatment may last up to 36 weeks. Treatment may include counseling, NRT (patches and/or nicotine lozenges), or prescription medication (varenicline or bupropion). Treatment will be determined by a study doctor.
- Participants will also have three study visits at 4, 6, and 12 months after starting treatment. Each visit may take up to 2 hours. At the study visits, participants will have different kinds of tests. They will provide blood and urine samples, and have carbon monoxide breath tests. They will also fill out forms about mood and tobacco cravings.
- During treatment, participants will have clinic visits once or twice a week for counseling and to monitor tobacco use and withdrawal symptoms. Counseling sessions will work on dealing with tobacco cravings. Each visit may take up to 90 minutes.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Tobacco Cessation:Treatment Delivery and Predictors of Outcome|
- Tobacco abstinence, defined as no tobacco use by any measure (self-report, urine cotinine, and breath CO) during the assessment period. [ Time Frame: prospective ] [ Designated as safety issue: No ]
- A reduction in tobacco use of at least 50% (e.g., from 10 cigarettes per day to 5 cigarettes per day). [ Time Frame: prospective ] [ Designated as safety issue: No ]
- Nicotine withdrawal signs and symptoms and tobacco craving (VAS) during treatment and at follow-up; duration of continuous abstinence from tobacco (self-report) and 7-day point prevalence smoking abstinence rates at follow-up time points. [ Time Frame: prospective ] [ Designated as safety issue: No ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||March 2023|
|Estimated Primary Completion Date:||March 2023 (Final data collection date for primary outcome measure)|
The purpose of this protocol is to create a mechanism whereby the intramural program of the NIDA in Baltimore, MD can evaluate and treat a broad range of people who use tobacco products. Through this protocol, participants will receive state-of-the-art treatment for their tobacco use. The secondary objective is to investigate predictors of success in tobacco-use-cessation treatment.
Participants will be individuals who present to the NIDA IRP seeking to quit tobacco use (smoked and smokeless). Enrollment may occur as part of participation in another NIDA IRP study. We will enroll up to 1000 participants. All individuals who give signed informed consent and who attend at least one study visit will be considered evaluable. We will not replace study dropouts.
After undergoing initial screening and signing the IRB-approved consent form, participants will be enrolled in our outpatient smoking treatment-research clinic at the NIDA IRP. The study will last up to one year, with active treatment lasting up to 36 weeks and follow-up visits 4, 6, and 12 months after the first treatment visit. Treatment will include counseling and pharmacotherapy (nicotine replacement, bupropion, or varenicline, if warranted and medically appropriate). During active treatment, participants will visit the clinic up to twice a week for counseling, dispensing of medication, and monitoring of tobacco use, withdrawal symptoms, and reporting of any adverse events. Visits may take up to 90 minutes.
There are no outcome measures for the primary objective. For the secondary objectives, the outcome measures are (1) tobacco abstinence, as determined by self-reported tobacco use, urinary cotinine, and (in tobacco smokers only) breath CO, and (2) reduction in tobacco use of at least 50% (e.g., from 10 cigarettes per day to 5 cigarettes per day). Other outcome measures for the secondary objectives include duration of abstinence, nicotine withdrawal signs and symptoms, and tobacco craving. Behavioral, psychological, medical, and genetic characteristics and tobacco-use history will be assessed at the beginning of the study as predictors of treatment outcome and at follow-up.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01859364
|Principal Investigator:||Carol Myers, Ph.D.||National Institute on Drug Abuse (NIDA)|