Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder

Tobacco Use Disorder Clinical Trial

Official title:

Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04092101
• Other study ID #: CHRMS19-0130
• Secondary ID: U54DA036114-06
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 18, 2019
• Est. completion date: January 2024

Study information

• Verified date: August 2023
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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), biomarkers of tobacco toxicant exposure, brain function and structure, and airway inflammation (fractional nitric oxide concentration in exhaled breath [FeNO]).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 310
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Tobacco Use Disorder

Intervention

Other:
• Cigarettes with varying nicotine content
1) Altering the nicotine content of the tobacco research cigarette
• E-Cigarettes
1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Shirley Plucinski	Burlington	Vermont

Sponsors (4)

Lead Sponsor	Collaborator
University of Vermont	Food and Drug Administration (FDA), Johns Hopkins University, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Cigarettes Smoked Per Day	Cigarettes per day will be assessed for use of cigarettes with different nicotine content.	16 weeks