Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder

• Status: Completed
• Trial end date: 2021-04-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Battelle Memorial Institute
• Treatments: Ethanol; Nicotine

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).