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Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04092101
Recruitment Status : Suspended (COVID19 pandemic)
First Posted : September 17, 2019
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Food and Drug Administration (FDA)
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Information provided by (Responsible Party):
Stacey C. Sigmon, University of Vermont

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


Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Other: Cigarettes with varying nicotine content Other: E-Cigarettes Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Double blind dosing of tobacco cigarette nicotine levels.
Primary Purpose: Basic Science
Official Title: Low Nicotine Content Cigarettes in Vulnerable Populations: Opioid Use Disorder
Actual Study Start Date : September 24, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: RC 1 only
Research Cigarettes #1
Other: Cigarettes with varying nicotine content
1) Altering the nicotine content of the tobacco research cigarette

Experimental: RC 2 only
Research Cigarettes #2
Other: Cigarettes with varying nicotine content
1) Altering the nicotine content of the tobacco research cigarette

Experimental: RC 2 + EC 1
Research Cigarettes #2 plus E-cigarettes #1
Other: Cigarettes with varying nicotine content
1) Altering the nicotine content of the tobacco research cigarette

Other: E-Cigarettes
1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition

Experimental: RC 2 + EC 2
Research Cigarettes #2 plus E-cigarettes #2
Other: Cigarettes with varying nicotine content
1) Altering the nicotine content of the tobacco research cigarette

Other: E-Cigarettes
1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition




Primary Outcome Measures :
  1. Number of Cigarettes Smoked Per Day [ Time Frame: 16 weeks ]
    Cigarettes per day will be assessed for use of cigarettes with different nicotine content.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092101


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Vermont
Catie Markesich
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Food and Drug Administration (FDA)
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Investigators
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Principal Investigator: Stacey C. Sigmon, Ph.D. University of Vermont
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Responsible Party: Stacey C. Sigmon, Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT04092101    
Other Study ID Numbers: CHRMS19-0130
U54DA036114-06 ( U.S. NIH Grant/Contract )
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stacey C. Sigmon, University of Vermont:
Biomarkers of Exposure
Compensatory Smoking
Nicotine Dependence
Reduced Nicotine Cigarettes
Affective Disorders
Tobacco Withdrawal
Vulnerable Populations
E-Cigarettes
Additional relevant MeSH terms:
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Disease
Tobacco Use Disorder
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action