- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02990455
Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder (RedNic)
September 27, 2021 updated by: Battelle Memorial Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
47
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21209
- Battelle Memorial Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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 Names:
|
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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Alcohol drinks per day
Time Frame: 7 days
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
7 days
|
Subjective acceptability
Time Frame: 7 days
|
subjective response
|
7 days
|
Smoking compensation
Time Frame: 7 days
|
number of cigarettes per day during each 7-day period
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 14, 2017
Primary Completion (Actual)
April 21, 2021
Study Completion (Actual)
April 21, 2021
Study Registration Dates
First Submitted
December 7, 2016
First Submitted That Met QC Criteria
December 8, 2016
First Posted (Estimate)
December 13, 2016
Study Record Updates
Last Update Posted (Actual)
September 29, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Drinking Behavior
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcohol Drinking
- Alcoholism
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Agents
- Ganglionic Stimulants
- Nicotinic Agonists
- Cholinergic Agonists
- Nicotine
Other Study ID Numbers
- BMI-202181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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