Alcohol DrinkingPhase 1RedNicNCT02990455
Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder
A Phase 1 study testing Reduced nicotine cigarettes in people with Alcohol Drinking and Cigarette Smoking Toxicity, run by Battelle Memorial Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Cigarette Smoking Toxicity
- What is being tested?
- Reduced nicotine cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 21 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Battelle Memorial Institute
Baltimore, Maryland, 21209
About this study
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.
Read the 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.
- Conditions
- Alcohol Drinking, Cigarette Smoking Toxicity
- Being tested
- Reduced nicotine cigarettes
- Keywords
- alcohol, drinking, smoking, cigarette, nicotine
- Medical subject headings
- Alcohol Drinking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced nicotine cigarettesDrug
Also called Nicotine research 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Reduced nicotine cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol drinks per day
Measured: 7 days
Secondary outcomes (3)
Toxicant exposure
(1) boost in (a) exhaled carbon monoxide, (b) plasma nicotine, and (c) plasma cotinine, and (2) solanesol after laboratory smoking
Measured: 7 days
Subjective acceptability
subjective response
Measured: 7 days
Smoking compensation
number of cigarettes per day during each 7-day period
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start14 Nov 2017
- Primary completion21 Apr 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Battelle Memorial Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990455
- Sponsor's protocol ID
- BMI-202181
- Acronym
- RedNic
- Status last verified
- Sep 2021
- First submitted
- 7 Dec 2016
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Nicotine Cigarettes in Smokers With and Without Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT02990455
- Acronym / sponsor ID
- RedNic / BMI-202181
- Conditions
- Alcohol Drinking, Cigarette Smoking Toxicity
- Keywords
- alcohol, drinking, smoking, cigarette, nicotine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Battelle Memorial InstituteUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced Nicotine Cigarette - Moderate | Experimental | Drug: Reduced nicotine cigarettesNicotine 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 |
| Reduced Nicotine Cigarette - Low | Experimental | Drug: Reduced nicotine cigarettesNicotine 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 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- Has or is at-risk of serious alcohol-related consequences, defined as any of the following:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced nicotine cigarettesAlso: Nicotine research cigarettesParticipants 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. | Drug | Reduced Nicotine Cigarette - Low, Reduced Nicotine Cigarette - Moderate |
Primary outcome
Alcohol drinks per day
Time frame: 7 days
3 secondary outcomes
Toxicant exposure
Time frame: 7 days
Subjective acceptability
Time frame: 7 days
Smoking compensation
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Reduced nicotine cigarettes in people with Alcohol Drinking and Cigarette Smoking Toxicity, run by Battelle Memorial Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol drinks per day (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021; AzTrials last refreshed its copy on 7 Nov 2026.