Clinical trial NCT04535362: Nicotine's Potential Abuse With Menthol
Official title: Impact of Menthol on the Abuse Potential of Nicotine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Nicotine Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-09-01
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: subjects will be unblinded to smoking menthol or non menthol for two weeks before each test session. Each session will include 3 infusions in the same order: nicotine (1 mg per 70 kg body weight) delivered over 5 minutes, saline and nicotine (1 mg/ 70 kg) delivered over 2.5 minutes. Once the participants complete the test session, participants will be crossed-over to the alternative treatment.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To examine if switching from menthol to non-menthol cigarettes will change the dose-effect curves for positive subjective effects and alleviation of smoking urges as a function of nicotine delivery rate in smokers.

Detailed description: A placebo-controlled study that will recruit male and female menthol nicotine dependent smokers. Following screening and evaluation as described above, eligible participants will be enrolled in the study which will last about 4 weeks. Eligible, participants will be randomized to menthol or non-menthol smoking condition for 2 weeks (Phase 1) and then will be switched to the alternative condition for another 2 weeks (Phase 2). The smoking condition will be open label. Participants will be provided with free cigarettes in Phases 1 and 2. For the menthol condition, participants will be provided their usual brand of menthol cigarettes and for the non-menthol condition, they will be provided a matched-brand non-menthol cigarette (e.g., Newport Non-Menthol Gold 100s for those who smoke Newport Menthol Gold 100s). In week 2 of each Phase, participants will have a test session. Each session will include 3 infusions in the same order: nicotine (1 mg per 70 kg body weight) delivered over 5 minutes, saline and nicotine (1 mg/ 70 kg) delivered over 2.5 minutes. Once the participants complete the test session, participants will be crossed-over to the alternative treatment. The period between the 2 Phases will not be longer than one week.

Eligibility criteria: Inclusion Criteria:

* 1) Female and male smokers, aged 21 to 35 years, who have been smoking tobacco cigarettes for at least a year;
* 2) smoke ≥ 5 and less than 20 cigarettes per day;
* 3) urine cotinine levels \> 100 ng/mL consistent with nicotine intake of an active smoker
* 4) not seeking treatment at the time of the study for nicotine dependence;
* 5) in good health as verified by medical history, screening examination, and screening laboratory tests;
* 6) for women, not pregnant as determined by pregnancy screening, nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

* 1) history of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the subject to be in the study;
* 2) regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics);
* 3) current alcohol or substance dependence for any other recreational or prescription drugs other than nicotine;
* 4) use of e-cigarettes more than 10 days in the past 30 days;
* 5) urine drug screening indicating recent illicit drugs use (with the exception of marijuana).

Primary outcomes:
measure: Drug Effect Questionnaire - Stimulatory Effects
timeFrame: Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes
measure: Drug Effect Questionnaire - Pleasure Effect
timeFrame: Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes
measure: Drug Effect Questionnaire - Aversive Effect
timeFrame: Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes
measure: Drug Effect Questionnaire - Head Rush
timeFrame: Following 2 weeks of smoking, the procedure took over 3 hours, with measured effects at 2.5 minutes, 5 minutes and 10 minutes
Secondary outcomes:
measure: SAFTEE
timeFrame: up to one year
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Department of Veterans Affairs Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Mehmet Sofuoglu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: