Nicotine's Potential Abuse With Menthol

NCT ID: NCT04535362

Last Updated: 2024-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-28
• Study Completion Date: 2023-06-29

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.

Conditions

Nicotine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

menthol cigarettes

Will smoke only menthol cigarettes for two weeks

Group Type: ACTIVE_COMPARATOR

Nicotine

Intervention Type: DRUG

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.

non menthol cigarettess

Will only smoke non menthol cigarettes for two weeks

Group Type: ACTIVE_COMPARATOR

Nicotine

Intervention Type: DRUG

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.

Interventions

Nicotine

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.

Intervention Type: DRUG

Other Intervention Names

intravenous nicotine

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Sofuoglu

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Sofuoglu, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Department of Veterans Affairs Hospital

West Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2U54DA036151-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000029223

Identifier Type: -

Identifier Source: org_study_id