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Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder (RedNic)

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ClinicalTrials.gov Identifier: NCT02990455
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : May 25, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Erica Peters, Battelle Memorial Institute

Brief Summary:
The proposed research will investigate whether smokers with vs. without current at-risk alcohol drinking (ARD) respond to reduced nicotine cigarettes by increasing their alcohol consumption or smoke exposure, thereby diminishing the hypothesized public health benefit of these new products.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Cigarette Smoking Toxicity Drug: Reduced nicotine cigarettes Phase 1

Detailed Description:
The current proposal examines response to two RNCs, one with low nicotine content (RNC Low; 0.03mg) and one with moderate nicotine content (RNC Moderate; 0.8mg) in daily smokers with and without ARD. Participants (N = 70) will attend a total of five visits to the laboratory. The first visit will be to classify participants as either ARD (n = 35) or Non ARD (n = 35) and gather baseline data. Participants will be assigned to undergo two experimental conditions (i.e., exclusive smoking of RNC Low or Moderate in their home environment for 7 days) in a double-blind, randomized, crossover design. The two experimental conditions will be separated by a 7-day period of return to smoking of participants' own brand of cigarette. On the first and last day of each of the two experimental conditions, participants will smoke the assigned RNC in the laboratory, and data on toxicant exposure (i.e., boost in exhaled carbon monoxide and plasma nicotine and cotinine; solanesol from smoked cigarette butts), subjective acceptability (i.e., subjective response; risk perceptions; relative reinforcing efficacy); and smoking compensation (i.e., smoking topography measures) related to the smoked RNC will be collected. During each 7-day period of exposure to the RNCs, participants will provide daily data on alcohol and nicotine use, nicotine withdrawal, smoking urge, and alcohol urge via telephone-based Interactive Voice Response technology. The strength of our study design is that we can evaluate both between-group (i.e., ARD vs. Non ARD) and within-person (i.e., RNC Low vs. Moderate) differences in response to RNCs and, furthermore, can examine whether increased nicotine withdrawal, smoking urge, and alcohol urge mediate the relation between decreased nicotine exposure and alcohol consumption. Results from this study will show what mechanisms underlying drinking and smoking may need to be addressed in future integrated interventions for both problems and will immediately inform the practical implementation of market-wide reductions in cigarette nicotine content among smokers with ARD.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder
Actual Study Start Date : November 14, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol Smoking

Arm Intervention/treatment
Experimental: Reduced Nicotine Cigarette - Moderate
Nicotine Research Cigarette Drug Supply Program Category Codes NRC600 and NRC601 (menthol); each cigarette contains 0.8mg nicotine; participants will be instructed to smoke these cigarettes according to their usual smoking patterns
Drug: Reduced nicotine cigarettes
Participants will be assigned to undergo two experimental conditions (i.e., exclusive smoking of RNC Low or Moderate in their home environment for 7 days) in a double-blind, randomized, crossover design. The two experimental conditions will be separated by a 7-day period of return to smoking of participants' own brand of cigarette.
Other Name: Nicotine research cigarettes

Experimental: Reduced Nicotine Cigarette - Low
Nicotine Research Cigarette Drug Supply Program Category Codes NRC102 and NRC103 (menthol); each cigarette contains 0.03mg nicotine; participants will be instructed to smoke these cigarettes according to their usual smoking patterns
Drug: Reduced nicotine cigarettes
Participants will be assigned to undergo two experimental conditions (i.e., exclusive smoking of RNC Low or Moderate in their home environment for 7 days) in a double-blind, randomized, crossover design. The two experimental conditions will be separated by a 7-day period of return to smoking of participants' own brand of cigarette.
Other Name: Nicotine research cigarettes




Primary Outcome Measures :
  1. Alcohol drinks per day [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Toxicant exposure [ Time Frame: 7 days ]
    (1) boost in (a) exhaled carbon monoxide, (b) plasma nicotine, and (c) plasma cotinine, and (2) solanesol after laboratory smoking

  2. Subjective acceptability [ Time Frame: 7 days ]
    subjective response

  3. Smoking compensation [ Time Frame: 7 days ]
    number of cigarettes per day during each 7-day period



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 21-65;
  • Smokes ≥ 10 cigarettes/day for ≥ 2 years;
  • Has no immediate plans to quit drinking or smoking; and
  • Sufficient understanding of informed consent form and study procedures.

Exclusion Criteria:

  • Has or is at-risk of serious alcohol-related consequences, defined as any of the following:

    1. Meets DSM-5 criteria for current alcohol use disorder with the presence of 6 or more symptoms (i.e., current severity of severe)
    2. Has a Clinical Institute Withdrawal Assessment scale score of ≥8,
    3. Self-report of history of seizures, delirium, or hallucinations during alcohol withdrawal;
    4. Self-report of drinking to avoid withdrawal symptoms, or
    5. Self-report of a history of alcohol withdrawal treatment.
  • Women if pregnant, lactating, or not using a reliable form of birth control;
  • Has current serious psychiatric disorder;
  • Has DSM-5 current severe substance use disorder, other than nicotine;
  • Has current use of smokeless tobacco, pipes, cigars, e-cigarettes, or nicotine replacement products;
  • Displays clinically evident intoxication on any study visit, confirmed by breathalyzer test (breath alcohol level (BAL)>0.02 mg%);
  • Has difficulties with blood draws or poor venous access; or
  • Has significant smoking-related disease (by history).

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): NCT02990455


Contacts
Contact: Carson Smith, MPH 410-372-2705 smithc@battelle.org
Contact: Erica Peters, PhD 410-372-2708 finan@battelle.org

Locations
United States, Maryland
Battelle Memorial Institute Recruiting
Baltimore, Maryland, United States, 21209
Contact: Carson Smith, MPH    410-372-2705    smithc@battelle.org   
Contact: Zachary Rosenberry, MPH    410-372-2726    rosenberryz@battelle.org   
Principal Investigator: Erica N Peters, PhD         
Sponsors and Collaborators
Battelle Memorial Institute

Responsible Party: Dr. Erica Peters, Senior Research Scientist, Battelle Memorial Institute
ClinicalTrials.gov Identifier: NCT02990455     History of Changes
Other Study ID Numbers: BMI-202181
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Erica Peters, Battelle Memorial Institute:
alcohol
drinking
smoking
cigarette
nicotine

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Ethanol
Nicotine
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action