Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06239350 |
Other study ID # |
Pro00131124 |
Secondary ID |
1R01CA276066-01A |
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 8, 2024 |
Est. completion date |
January 1, 2029 |
Study information
Verified date |
April 2024 |
Source |
Medical University of South Carolina |
Contact |
Elizabeth Chapman |
Phone |
864.898.2992 |
Email |
chapmanb[@]musc.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.