Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder (RedNic)
Alcohol Drinking, Cigarette Smoking Toxicity
About this trial
This is an interventional basic science trial for Alcohol Drinking focused on measuring alcohol, drinking, smoking, cigarette, nicotine
Eligibility 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:
- Meets DSM-5 criteria for current alcohol use disorder with the presence of 6 or more symptoms (i.e., current severity of severe)
- Has a Clinical Institute Withdrawal Assessment scale score of ≥8,
- Self-report of history of seizures, delirium, or hallucinations during alcohol withdrawal;
- Self-report of drinking to avoid withdrawal symptoms, or
- 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).
Sites / Locations
- Battelle Memorial Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Reduced Nicotine Cigarette - Moderate
Reduced Nicotine Cigarette - Low
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
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