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Assisting Smokers to Switch to a JUUL E-Cigarette by Devaluing Combustible Cigarettes (RECON)

Primary Purpose

Smoking Cessation, Harm Reduction, E-Cig Use

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

JUUL

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Has signed the ICF and is able to understand the information provided in the ICF.
Is 21 to 65 years of age (inclusive) at screening.
Smokes ≥ 10 commercially available CCs per day (no brand restrictions), for the last 12 months.
Expired air CO reading of at least 10 ppm as assessed at the screening session.
Interested in switching to an electronic cigarette.
Willing and able to comply with the requirements of the study.
Owns a smartphone with text message and data capabilities compatible with necessary surveys.

Exclusion Criteria:

Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history).
PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening.
Planned use of an FDA-approved smoking cessation product during the study.
High Blood Pressure (systolic >150 mm Hg, diastolic >95 mm Hg) at screening.
Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2.
Coronary heart disease, structural cardiac disease (including, but not limited to valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac chest pain, or history of heart attack or heart failure.
Has received psychotherapy or behavioral treatments within 30 days of screening, or during the study.
Taking antidepressants or psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics).
Use of any of these products in the past 30 days:
1. Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates);
2. Experimental (investigational) drugs that are unknown to the subject;
3. Chronic opiate use.
Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for "Black & Mild" cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.
Pregnant or nursing (by self-report) or positive pregnancy test.

Sites / Locations

Rose Research CenterRecruiting
Rose Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

e-Cigarette Matched to Usual Brand Cigarette

e-Cigarette Unmatched to Usual Brand Cigarette

Arm Description

JUUL and cigarette flavor matched ("Mint" for menthol smokers and "Virginia Tobacco" for non-menthol smokers);

JUUL and cigarette flavor unmatched ("Virginia Tobacco" for menthol smokers and "Mint" for non-menthol smokers).

Outcomes

Primary Outcome Measures

Effects of devaluation on switching from cigarettes to the JUUL e-cigarette

Biochemically verified smoking abstinence during weeks 9-12, i.e., self-report of no smoking confirmed by an expired air CO reading of <5 ppm.

Secondary Outcome Measures

Changes in cigarette reward with subsequent switching behavior

Characterize changes in the two primary scales of the Cigarette Evaluation Questionnaire (mCEQ), assessing smoking satisfaction and psychological reward, over the first week of the study period. The mCEQ uses a 7-point scale (0=Not at all; 1=Very little; 2=A little; 3=Moderately; 4=A lot, 5=Quite a lot; 6=Extremely) to measure the following subscales: Satisfaction, Psychological Reward, Enjoyment of Respiratory Tract Sensations, Craving Reduction, Aversion.

Full Information

NCT ID

NCT04188197

First Posted

September 9, 2019

Last Updated

July 22, 2020

Sponsor

Rose Research Center, LLC

Collaborators

Foundation for a Smoke Free World INC

1. Study Identification

Unique Protocol Identification Number

NCT04188197

Brief Title

Assisting Smokers to Switch to a JUUL E-Cigarette by Devaluing Combustible Cigarettes

Acronym

RECON

Official Title

Assisting Smokers to Switch to a JUUL E-Cigarette by Devaluing Combustible Cigarettes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 26, 2019 (Actual)

Primary Completion Date

December 15, 2020 (Anticipated)

Study Completion Date

December 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rose Research Center, LLC

Collaborators

Foundation for a Smoke Free World INC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will evaluate a reward devaluation strategy in which smokers use the JUUL e-cigarette immediately before any combustible cigarettes (CCs) are smoked. This procedure is predicted to accomplish three goals: 1) the rewarding effects of CC will be disrupted because subjects will already have attained fairly high peak nicotine concentrations immediately before smoking the cigarette. This reduces the rewarding effect of smoking, in part from receptor desensitization that occurs following nicotine exposure, which reduces the response to a subsequent dose of nicotine, and in part from satiating the drive to smoke; 2) the use of the JUUL will become associated with the same cues that elicit smoking, thereby promoting the substitution of JUUL use for CC use; and 3) ad libitum nicotine intake from the JUUL and its rewarding effects will be maximized because, unlike CC, they will be experienced after a period of nicotine deprivation. Thus, despite a lower per-puff nicotine dose relative to CC, the pharmacologic impact and reinforcing effect will be maximized. The study will evaluate two flavors (Mint and Virginia Tobacco), randomly assigned, to determine if flavor assignment (similar to the subjects' usual brand of CC or different than the subjects usual brand CC) has an effect on the success of this reconditioning procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Smoking Cessation, Harm Reduction, E-Cig Use, Cigarette Smoking, Tobacco Dependence, Tobacco Use Cessation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

e-Cigarette Matched to Usual Brand Cigarette

Arm Type

Experimental

Arm Description

JUUL and cigarette flavor matched ("Mint" for menthol smokers and "Virginia Tobacco" for non-menthol smokers);

Arm Title

e-Cigarette Unmatched to Usual Brand Cigarette

Arm Type

Experimental

Arm Description

JUUL and cigarette flavor unmatched ("Virginia Tobacco" for menthol smokers and "Mint" for non-menthol smokers).

Intervention Type

Other

Intervention Name(s)

JUUL

Intervention Description

Subjects will be instructed to use the JUUL as often as they like during the 12-week product use period. They will also be instructed to use JUUL immediately before each cigarette to relieve their craving as much as possible before smoking their usual brand. The JUUL will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute JUUL for cigarettes by the end of the first week of use.

Primary Outcome Measure Information:

Title

Effects of devaluation on switching from cigarettes to the JUUL e-cigarette

Description

Biochemically verified smoking abstinence during weeks 9-12, i.e., self-report of no smoking confirmed by an expired air CO reading of <5 ppm.

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Changes in cigarette reward with subsequent switching behavior

Description

Time Frame

Week 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Has signed the ICF and is able to understand the information provided in the ICF. Is 21 to 65 years of age (inclusive) at screening. Smokes ≥ 10 commercially available CCs per day (no brand restrictions), for the last 12 months. Expired air CO reading of at least 10 ppm as assessed at the screening session. Interested in switching to an electronic cigarette. Willing and able to comply with the requirements of the study. Owns a smartphone with text message and data capabilities compatible with necessary surveys. Exclusion Criteria: Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history). PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening. Planned use of an FDA-approved smoking cessation product during the study. High Blood Pressure (systolic >150 mm Hg, diastolic >95 mm Hg) at screening. Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2. Coronary heart disease, structural cardiac disease (including, but not limited to valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac chest pain, or history of heart attack or heart failure. Has received psychotherapy or behavioral treatments within 30 days of screening, or during the study. Taking antidepressants or psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics). Use of any of these products in the past 30 days: Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, methamphetamines, or opiates); Experimental (investigational) drugs that are unknown to the subject; Chronic opiate use. Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for "Black & Mild" cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of screening. Pregnant or nursing (by self-report) or positive pregnancy test.

Facility Information:

Facility Name

Rose Research Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28262

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Derek Mercedes

Phone

704-350-2999

derek.mercedes@roseresearchcenter.com

First Name & Middle Initial & Last Name & Degree

Jed E Rose, Ph.D.

First Name & Middle Initial & Last Name & Degree

Perry Willette, M.D.

Facility Name

Rose Research Center

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27617

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stacy L Drew, MS, MHS, PA-C

Phone

919-325-2345

stacy.drew@roseresearchcenter.com

First Name & Middle Initial & Last Name & Degree

Tanaia Loeback

tanaia.loeback@roseresearchcener.com

First Name & Middle Initial & Last Name & Degree

Jed E Rose, Ph.D.

First Name & Middle Initial & Last Name & Degree

Perry Willette, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Assisting Smokers to Switch to a JUUL E-Cigarette by Devaluing Combustible Cigarettes

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