Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder

Completed · Phase 1

Conditions studied: Alcohol Drinking, Cigarette Smoking Toxicity

In brief

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.

Key facts

Study ID

NCT02990455

Run by

Battelle Memorial Institute

People needed

47

Starts

2017-11-14

Expected to finish

2021-04-21

Last updated by the study team

2021-09-29

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Battelle Memorial Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.