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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

December 7, 2016
December 13, 2016
May 25, 2018
November 14, 2017
December 2019   (Final data collection date for primary outcome measure)
Alcohol drinks per day [ Time Frame: 7 days ]
Same as current
Complete list of historical versions of study NCT02990455 on ClinicalTrials.gov Archive Site
  • 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
  • Subjective acceptability [ Time Frame: 7 days ]
    subjective response
  • Smoking compensation [ Time Frame: 7 days ]
    number of cigarettes per day during each 7-day period
Same as current
Not Provided
Not Provided
 
Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder
Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
  • Alcohol Drinking
  • Cigarette Smoking Toxicity
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 - 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
    Intervention: Drug: Reduced nicotine 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
    Intervention: Drug: Reduced nicotine cigarettes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
Same as current
December 2019
December 2019   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult, Older Adult)
Yes
Contact: Carson Smith, MPH 410-372-2705 smithc@battelle.org
Contact: Erica Peters, PhD 410-372-2708 finan@battelle.org
United States
 
 
NCT02990455
BMI-202181
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Dr. Erica Peters, Battelle Memorial Institute
Battelle Memorial Institute
Not Provided
Not Provided
Battelle Memorial Institute
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP