Clinical trial NCT06239350: Young Adult Tobacco/Nicotine and Cannabis Co-use
Official title: The Impact of Cannabis and Tobacco/Nicotine Product Co-use in Young Adults: Prospective Cessation Evaluation and Substitution
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tobacco Use Disorder
Nicotine Dependence
Keywords: tobacco
vaping
cessation
cannabis/marijuana
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-02-02
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this project is to better understand the relationship between tobacco/nicotine and cannabis using behavioral economics during a tobacco/nicotine quit attempt. All participants will receive tobacco/nicotine cessation treatment (smoking and/or vaping treatment) for 12 weeks. To qualify, participants must be between the ages of 18-25 and use tobacco products (smoke cigarettes and/or vape nicotine) and use cannabis (in any form). Participants do not need to be interested in quitting cannabis/marijuana to qualify. This study is being conducted by the Medical University of South Carolina. All procedures are conducted remotely and there is no in-person visits are needed.

Detailed description: The co-use of nicotine/tobacco products and cannabis among young adults is prevalent and varies widely in terms of patterns and products of use. Nicotine-cannabis co-use among this age group may adversely affect treatment and other clinical outcomes, yet little is known regarding the underlying relationship between nicotine and cannabis and the resulting treatment implications, particularly during an attempt to quit or reduce use of one or both substances. Prior literature on the treatment implications of co-use, including results from our group, suggest that cannabis serves as an obstacle to nicotine cessation for a sub-set who use both products, though the literature is mixed. Past studies also suffer from important limitations, resulting in critical gaps in our understanding, with only 2 secondary analyses published from youth tobacco trials on the impact of co-use. To date, there are no prospective studies that have examined the treatment implications of nicotine-cannabis co-use or the underlying relationship between substances among young adults when engaged in a quit attempt.

Therefore, the overall goal of this project is to characterize and evaluate the underlying relationship between nicotine/tobacco and cannabis and its impact on nicotine cessation through a behavioral economics framework. This study will determine how impactful cannabis co-use may be on nicotine cessation and which individuals who co-use experience greater difficulty achieving cessation. To accomplish this goal, the investigators propose a completely remote, prospective, 12-week nicotine cessation trial among young adults (ages 18-25; N=350) from across the United States who use nicotine (vaping, cigarettes or both) and cannabis products regularly. Nicotine treatment includes remote contingency management (CM), text-based resources and counseling, while cannabis use will not be addressed. Biochemical verification (through oral fluid samples) and self-reports (mobile daily diaries) of substance use will be collected. The aims of this proposed study are to: 1) evaluate the impact of behavioral economically derived measures of substance substitutability on end of treatment nicotine abstinence (Aim 1); 2) determine if treatment-induced nicotine abstinence, reduction, and/or withdrawal (a) is associated with co-occurring changes in cannabis demand and use and (b) if substance substitutability modifies this relationship (Aim 2); and 3) assess the reciprocal prospective relationship between patterns of nicotine and cannabis use during nicotine treatment (Aim 3).

Evaluating nicotine-cannabis co-use as part of a prospective treatment study through a behavioral economics framework has never been conducted and will be important to informing the literature regarding individual co-use pattern differences, compensatory cannabis use, and treatment success. Nicotine cessation treatment in young adults is a growing body of work and the role of cannabis co-use, and results from the proposed study, will inform clinical care and guide tailored treatment recommendations to promote successful and sustained abstinence.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18 and 25 years old
* Must use at least one nicotine or tobacco product (nicotine vaping and/or cigarettes) on at least 20 out of the past 30 days for at least the past 3 months
* Must express interest in nicotine cessation (all products)
* Must submit a positive instant-read, oral fluid cotinine sample prior to enrollment
* Must report use of cannabis on at least 10 out of the past 30 days
* Must submit a positive instant-read cannabinoid test prior to enrollment
* Must be able to provide informed consent

Exclusion Criteria:

* Any significant or acutely unstable medical, psychiatric, or substance use problem that would contraindicate research, interfere with safety, compromise data integrity, or preclude consistent study participation
* Pregnant (self-report) or trying to become pregnant
* Self-reported use of medications with smoking cessation efficacy
* Immediate interest in cannabis cessation or treatment

Primary outcomes:
measure: 7-day point prevalence nicotine abstinence at the end of treatment (Week 12)
timeFrame: Final 7 days of treatment (Weeks 11-12 of tobacco treatment)
Secondary outcomes:
measure: Changes in cannabis use during nicotine cessation treatment
timeFrame: Final 4 weeks of study treatment (Weeks 8-12)
Other outcomes:
measure: Behavioral economic demand for cannabis during nicotine treatment
timeFrame: Throughout tobacco treatment (Weeks 1-12)
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina - Charleston
state: South Carolina
Study officials:
References: