Very Low-Nicotine Cigarettes in Smokers With SUD

NCT01989507 | Completed Phase 2

• 1 other identifier: R01DA034628-01A1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Keywords

tobacco smoking; smoking cessation; nicotine dependence; tobacco use disorder

Outcome Measures

Primary Outcomes (1)

• 7-day point-prevalence smoking abstinence

  self-report of past 7 days abstinence confirmed by expired carbon monoxide (CO) reading of 6 ppm or less

  6 weeks

Secondary Outcomes (10)

• Total N'-nitrosonornicotine (NNAL)

  6 weeks

• Number of cigarettes smoked per day

  6 weeks

• Number of substance use days

  6 months

• Change in Beck Depression Inventory

  Baseline and 6 weeks

• Total N'-nitrosonornicotine (NNN)

  6 weeks

Other Outcomes (4)

• Minnesota Nicotine Withdrawal Scale

  6 weeks

• Penn Alcohol Craving Scale

  6 weeks

• Drug Craving Questionnaire

  6 weeks

Study Arms (2)

Very low nicotine content cigarettes

EXPERIMENTAL

Cigarettes with Nicotine Yield 0.07 ± 0.02

Drug: Nicotine; Behavioral: behavioral counseling for smoking cessation

Conventional nicotine content cigarettes

ACTIVE COMPARATOR

Cigarettes with Nicotine Yield 0.8 ± 0.15

Drug: Nicotine; Behavioral: behavioral counseling for smoking cessation

Interventions

Nicotine DRUG

Conventional nicotine content cigarettes; Very low nicotine content cigarettes

behavioral counseling for smoking cessation BEHAVIORAL

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

Conventional nicotine content cigarettes; Very low nicotine content cigarettes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University's Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Tobacco Smoking; Smoking Cessation

Interventions

Nicotine; Behavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking; Behavior; Tobacco Use; Health Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Damaris J Rohsenow, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

• Rosemarie A Martin, PhD

  Brown University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 21, 2013
• Study Start: April 1, 2014
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

US (1)