Very Low-Nicotine Cigarettes in Smokers With SUD

NCT ID: NCT01989507

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2021-05-31

Brief Summary

The purpose of this study is to determine the efficacy, acceptability and unintended consequences of very low nicotine content cigarettes (VLNCC) in smokers with current or past year substance use disorders (SUD). The primary aim of this study is to determine whether 6 weeks of VLNCC compared to normal nicotine content cigarettes (NNCC) will result in more smoking cessation over 6 months and reduce cigarette use, cotinine, and biomarkers of toxicity. We will also assess the effects of VLNCC versus NNCC cigarettes on frequency of substance use and substance cravings (drugs and alcohol) because this is relevant to the safety of these products among smokers with SUD. Secondary aims are to study effects on cigarette craving, nicotine withdrawal and dependence, and depressed mood. Methods: Random assignment to VLNCC versus NNCC of up to 312 smokers with SUD will be balanced by gender, degree of tobacco dependence, and recent drug and alcohol use. All smokers will be provided with smoking counseling. Assessments over 6 months will assess effects both during the 6 weeks of using research cigarettes and after return to usual cigarettes. The importance is in determining the viability and safety of this public health strategy in terms of effects on both smoking and other substance use in a highly addicted population, which is essential to determine before the FDA implements this policy.

Detailed Description

The 2009 passage of the Family Smoking Prevention and Tobacco Control Act (FSPTCA) gave the Food and Drug Administration (FDA) the authority to reduce levels of nicotine in cigarettes if appropriate for public health. This project addresses an area targeted for study by NIH and the FDA to assess the impact of products with reduced toxicity on tobacco use behaviors. Very-low nicotine content cigarettes (VLNCC) have been shown in some studies with smokers from the general population to reduce craving and withdrawal for tobacco relative to abstinence with little or no compensatory smoking, suggesting that a mandated reduction in the nicotine yield of cigarettes could substantially reduce smoking rates. This may be a particularly effective method of reducing smoking and smoking-related disease in special populations that have very high rates of tobacco dependence, such as people with substance use disorders (SUD). However, the consequences of this policy for smokers with SUD have not been investigated, and a call has gone out for studies of the safety of these products with vulnerable populations such as these. The purpose of this study is to determine the efficacy, acceptability and unintended consequences of VLNCC in smokers with SUD (current or past year) currently abstinent from hard drugs. The primary aims are to determine whether VLNCC will increase smoking cessation and reduce cigarette use, cotinine, and biomarkers of toxicity in smokers with SUD relative to baseline and to those randomized to a normal nicotine content cigarette (NNCC), and to determine any unintended effects of VLNCC on substance use and cravings to use substances so as to investigate safety. Secondary aims are to study effects on cigarette craving and nicotine withdrawal and dependence (mechanisms), and state depression (safety). A 2-group between-group by pre-post design will compare 6 weeks of VLNCC to NNCC; all smokers will also be provided with smoking counseling. Follow-up over 6 months will assess effects after return to usual cigarettes. The importance is in determining the viability and safety of this public health strategy in terms of effects on both smoking and other substance use in a highly addicted population, which is essential to determine before the FDA implements this policy.

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Very low nicotine content cigarettes

Cigarettes with Nicotine Yield 0.07 ± 0.02

Group Type: EXPERIMENTAL

Nicotine

Intervention Type: DRUG

behavioral counseling for smoking cessation

Intervention Type: BEHAVIORAL

Brief session of Brief advice. Assess smoking and provide assistance with quitting via coping skills.

Conventional nicotine content cigarettes

Cigarettes with Nicotine Yield 0.8 ± 0.15

Group Type: ACTIVE_COMPARATOR

Nicotine

Intervention Type: DRUG

behavioral counseling for smoking cessation

Intervention Type: BEHAVIORAL

Brief session of Brief advice. Assess smoking and provide assistance with quitting via coping skills.

Interventions

Nicotine

Intervention Type: DRUG

behavioral counseling for smoking cessation

Brief session of Brief advice. Assess smoking and provide assistance with quitting via coping skills.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnostic and Statistical Manual-5 criteria for current or past year substance use disorder
• smoke 10+ cigarettes/day for past 6 months
• zero breath alcohol, negative urine drug tests and a self-report of no drug use in the past 30 days on day of informed consent
• score of 4-8 on the Contemplation Ladder (individuals interested in quitting smoking someday and/or have thought about quitting)

Exclusion Criteria

• active psychosis as evidenced by hallucinations or delusions
• actively quitting smoking or current use of any nicotine replacement or other smoking cessation treatment
• medication contraindications for smoking cessation (smoking cessation may change the bioavailability of antipsychotics, warfarin, theophylline and insulin)
• other medications that could affect smoking (naltrexone, buprenorphine, acamprosate, anti-seizure medications, disulfiram)
• if on psychotropic medications, not stabilized on psychotropic medications (i.e., anti-depressant, anti-anxiety or anti-manic medications changed within past 4 weeks)
• inability to understand informed consent in a test (true-false questions) on the key elements of the consent form

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Damaris J. Rohsenow, Ph.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Damaris J Rohsenow, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Rosemarie A Martin, PhD

Role: STUDY_DIRECTOR

Brown University

Locations

Brown University's Center for Alcohol and Addiction Studies

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

R01DA034628-01A1

Identifier Type: NIH

Identifier Source: org_study_id

View Link