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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

    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).

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: Reduced nicotine cigarettes
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:
  • Nicotine research cigarettes
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
Drug: Reduced nicotine cigarettes
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:
  • Nicotine research cigarettes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Alcohol drinks per day
Time Frame: 7 days
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Battelle Memorial Institute

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 21, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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