Varenicline & Motivational Advice for Smokers With Substance Use Disorders

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the effects of 12 weeks of varenicline as compared to nicotine replacement therapy for smoking cessation among outpatients in treatment for substance use disorders. The intervention also incorporates counseling (Brief Advice), (adapted for sobriety settings), skills training and medication management.

Clinical Trial Description

People with substance use disorders (SUD) have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking. Brief advice (BA), to motivate cessation, produced some benefit but low abstinence rates for smokers with SUDs while adding free transdermal nicotine replacement therapy (NRT) improved short-term cessation rates. Varenicline has been found to produce higher rates of short and long-term abstinence than bupropion or placebo. However, a comparison between the efficacy of varenicline and NRT has not yet conducted with people with SUDs. Given the lack of effectiveness for standard smoking treatments for this population, what needs to be known is whether varenicline would increase the smoking abstinence rates relative to NRT when all receive motivational counseling.

The primary aim of this study is to evaluate the effects of 12 weeks of varenicline as compared to NRT, using a two-group randomized placebo-controlled design on smoking cessation rates for 12 months among 274 outpatients in treatment for SUD. The counseling incorporates BA (adapted slightly for sobriety settings by directly addressing barriers and concerns expressed by substance abusers), skills training and medication management. Confirmed point-prevalence and sustained abstinence will be assessed at 3 and 6 a months after the start of treatment. Secondary aims will examine potential mediators of effect including within-treatment abstinence, craving, and nicotine withdrawal levels.

The potential significance is to add to knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this difficult population. No study published to date has compared varenicline to NRT for efficacy with patients with SUD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00756275
Study type	Interventional
Source	Brown University
Contact
Status	Completed
Phase	N/A
Start date	January 2009
Completion date	September 2014

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	`NCT04043728` - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study	N/A
Completed	`NCT04617444` - The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function	N/A
Completed	`NCT02796391` - Facilitating Smoking Cessation With Reduced Nicotine Cigarettes	Phase 2
Completed	`NCT03397511` - Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City	N/A
Not yet recruiting	`NCT05188287` - A Culturally Tailored Smartphone Application for African American Smokers	N/A
Recruiting	`NCT05264428` - The Effect of Honey on Lessening the Withdrawal Symptoms	N/A
Recruiting	`NCT05846841` - Personalized Tobacco Treatment in Primary Care (MOTIVATE)	N/A
Completed	`NCT04133064` - Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study	N/A
Completed	`NCT03187730` - Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants	Phase 4
Completed	`NCT03474783` - To Explore the Factors Affecting the Effectiveness of Smoking Cessation	N/A
Completed	`NCT04635358` - Feasibility Study of Smoking Cessation for the Staff of a Hospital Center	N/A
Terminated	`NCT03670264` - BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation	N/A
Not yet recruiting	`NCT06307496` - VIDeOS for Smoking Cessation	N/A
Completed	`NCT03206619` - A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
Completed	`NCT02997657` - Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial	N/A
Completed	`NCT02905656` - Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit	N/A
Completed	`NCT02239770` - Pharmacokinetics of Nicotine Film in Smokers	N/A
Completed	`NCT02562521` - A Smoking Cessation Intervention for Yale Dining Employees	Phase 4
Recruiting	`NCT02422914` - Benefits of Tobacco Free Cigarette	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Varenicline and Motivational Advice for Smokers With Substance Use Disorders — VARSUD

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms