Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder

NCT02990455 | Completed Phase 1

• 1 other identifier: BMI-202181
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking; Cigarette Smoking Toxicity

Keywords

alcohol; drinking; smoking; cigarette; nicotine

Outcome Measures

Primary Outcomes (1)

• Alcohol drinks per day

  7 days

Secondary Outcomes (3)

• Toxicant exposure

  7 days

• Subjective acceptability

  7 days

• Smoking compensation

  7 days

Study Arms (2)

Reduced Nicotine Cigarette - Moderate

EXPERIMENTAL

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

Reduced Nicotine Cigarette - Low

EXPERIMENTAL

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

Interventions

Reduced nicotine cigarettes DRUG

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.

Also known as: Nicotine research cigarettes

Reduced Nicotine Cigarette - Low; Reduced Nicotine Cigarette - Moderate

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Battelle Memorial Institute: lead

Study Sites (1)

Battelle Memorial Institute

Baltimore, Maryland, 21209, United States

Location

MeSH Terms

Conditions

Alcohol Drinking; Smoking

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 13, 2016
• Study Start: November 14, 2017
• Primary Completion: April 21, 2021
• Study Completion: April 21, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)