Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder

NCT ID: NCT04092101

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-18
• Study Completion Date: 2023-11-27

Brief Summary

Prevalence of smoking among individuals with opioid use disorder (OUD) is six-fold that of the general US adult population. The mortality rate of opioid-dependent smokers is four times that of opioid-dependent nonsmokers, and their response to smoking cessation interventions is notoriously poor. A national policy of reducing the nicotine content of cigarettes has the potential to be an effective method of reducing tobacco use prevalence, dependence, and related adverse health outcomes. Controlled trials in the general smoker population have demonstrated that switching smokers to low nicotine content cigarettes results in reductions in cigarettes per day (CPD), dependence and tobacco toxicant exposure, with few adverse consequences. The investigators believe that the impact of reduced nicotine standards on use of combusted cigarettes in this population will be moderated considerably by other tobacco market conditions including (1) availability of alternative sources of non-combusted nicotine, and (2) whether these alternatives are available under conditions that optimize their appeal. The investigators hypothesize the same for other vulnerable populations as well, but achieving significant reductions in use of combusted cigarettes in smokers with OUD seems especially unlikely in the absence of readily available and appealing alternative sources of non-combusted nicotine.

The goal of the proposed trial is to experimentally model whether increased availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) will enhance the effectiveness of a reduced nicotine standard for cigarettes in smokers with OUD. Additionally, the investigators will test whether allowing participants to personalize the favor of the e-liquid alters any moderating effects their availability may have on tobacco cigarette smoking.

Daily smokers who are receiving methadone or buprenorphine treatment will be recruited at University of Vermont and Johns Hopkins University.

The investigators will study two research cigarettes referred to here as RC1 and RC2. One of these cigarettes will be a normal nicotine content cigarette and the other will be a reduced nicotine content cigarette. Investigators will study two e-cigarette conditions referred to here as EC1 and EC2. Both e-cigarette conditions will involve the same commercially available devices and same nicotine-containing e-liquid, but in one condition that e-liquid will be available only in tobacco flavor while in the other condition that e-liquid will be available in multiple flavors from which participants can choose based on personal taste preference. Participants will be assigned to one of the following four study conditions: (1) RC1 only; (2) RC2 only; (3) RC2 + EC1; (4) RC2 + EC2.

Participants will be asked to use only their assigned study products for 16 weeks. Outcome measures include total CPD, cigarette demand assessed by behavioral economics-based purchase tasks, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), and biomarkers of tobacco toxicant exposure.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

RC 1 only

Research Cigarettes #1

Group Type: EXPERIMENTAL

Cigarettes with varying nicotine content

Intervention Type: OTHER

1\) Altering the nicotine content of the tobacco research cigarette

RC 2 only

Research Cigarettes #2

Group Type: EXPERIMENTAL

Cigarettes with varying nicotine content

Intervention Type: OTHER

1\) Altering the nicotine content of the tobacco research cigarette

RC 2 + EC 1

Research Cigarettes #2 plus E-cigarettes #1

Group Type: EXPERIMENTAL

Cigarettes with varying nicotine content

Intervention Type: OTHER

1\) Altering the nicotine content of the tobacco research cigarette

E-Cigarettes

Intervention Type: OTHER

1\) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition

RC 2 + EC 2

Research Cigarettes #2 plus E-cigarettes #2

Group Type: EXPERIMENTAL

Cigarettes with varying nicotine content

Intervention Type: OTHER

1\) Altering the nicotine content of the tobacco research cigarette

E-Cigarettes

Intervention Type: OTHER

1\) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition

Interventions

Cigarettes with varying nicotine content

1\) Altering the nicotine content of the tobacco research cigarette

Intervention Type: OTHER

E-Cigarettes

1\) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Maintained on opioid medication
• 21 to 70 years old

Exclusion Criteria

• Not maintained on opioid medication
• Under 21 years old
• Over 70 years old

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Stacey C. Sigmon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stacey C. Sigmon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Shirley Plucinski

Burlington, Vermont, United States

Countries

United States

References

Higgins ST, Sigmon SC, Tidey JW, Heil SH, Gaalema DE, Lee DC, DeSarno MJ, Klemperer EM, Menson KE, Cioe PA, Plucinski S, Wiley RC, Orr E. Reduced Nicotine Cigarettes and E-Cigarettes in High-Risk Populations: 3 Randomized Clinical Trials. JAMA Netw Open. 2024 Sep 3;7(9):e2431731. doi: 10.1001/jamanetworkopen.2024.31731.

Reference Type: DERIVED

PMID: 39240566 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U54DA036114-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHRMS19-0130

Identifier Type: -

Identifier Source: org_study_id