Sex Differences in the Interface between Cannabis Use and Stress among Emerging Adults

Date Added
May 2nd, 2023
PRO Number
Pro00127995
Researcher
Kevin Gray

List of Studies


Keywords
Adolescents, Drug Studies, Psychiatry, Substance Use
Summary

This study is enrolling emerging adults (ages 18-25) with cannabis use disorder (CUD) to examine sex differences in (a) cannabis withdrawal symptoms during short-term cannabis abstinence, (b) cannabidiol (CBD) versus placebo effects on stress reactivity during short-term cannabis abstinence, and (c) the relationship between stress reactivity and time to cannabis relapse after short-term cannabis abstinence. The proposed study is designed to reveal sex differences and guide the development of tailored treatments that address factors disproportionately affecting emerging adult females with CUD.

Participants will complete an assessment visit to determine eligibility. Eligible participants will be scheduled for their next visit and will be instructed to abstain from cannabis use for 3 days. Participants will be set up with a phone application (app) and given instructions on its use. This app will send twice daily, random surveys everyday throughout study participation with questions about cannabis use, cravings, and overall mood. Participants will also complete twice daily saliva samples.

At the end of the 3 days, participants will return to the clinic for their second visit. Participants will complete a urine and blood sample at each visit. After eating a snack, participants will receive one dose of CBD (800mg) or placebo and then participate in a stress task. Upon completion of the stress task, participants will complete 3 saliva samples and then be discharged after evaluation by research staff. After the completion of Visit 2, participants will continue to complete twice daily surveys for 10 days. The study will last approximately 14 days.

There are risks involved with participating in this study, including risks associated with CBD, risks associated with the stress task and study procedures, emotional distress from answering personal questions, and loss of confidentiality. There is a risk of experiencing cannabis withdrawal symptoms during the 3-day period of cannabis abstinence. Some potential risks related to CBD include dry mouth, diarrhea, reduced appetite, drowsiness, and fatigue. There is a risk of loss of confidentiality, but the researchers will code the samples and research information to protect privacy. There are no direct benefits to the participant, but we hope the knowledge gained will help us inform future clinical strategies to address cannabis use in emerging adults.

Institution
MUSC
Recruitment Contact
Sarah Bourne
843-792-5239
bourne@musc.edu

A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL-GROUP, PHASE 2B STUDY IN TREATMENT-SEEKING PATIENTS WITH CANNABIS USE DISORDER TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF AEF0117 IN REDUCING CANNABIS USE

Date Added
June 16th, 2022
PRO Number
Pro00119686
Researcher
Kevin Gray

List of Studies


Keywords
Drug Studies, Substance Use
Summary

The purpose of this research is to investigate how a trial drug, AEF0117, influences the effects of cannabis and if it is helpful in the treatment of Cannabis Use Disorder (CUD). This is a 20-week, randomized, double-blind, placebo-controlled, parallel-group outpatient clinical trial that will be conducted at approximately 10 research sites in the US.

Institution
MUSC
Recruitment Contact
Amanda Wagner
843-792-0484
wagne@musc.edu

A Proof-of-Concept Trial of N-Acetylcysteine for Adolescent Alcohol Use Disorder

Date Added
September 4th, 2018
PRO Number
Pro00080921
Researcher
Kevin Gray

List of Studies


Keywords
Adolescents, Alcohol, Substance Use
Summary

The purpose of this study is to evaluate the efficacy of the medication N-acetylcysteine (NAC) to help young people with alcohol use disorder. NAC is an over-the-counter supplement and antioxidant that has been approved by the Food and Drug Administration (FDA) in adults and children for other uses, but has not been approved by the FDA for treatment of alcohol use disorder. All participants will receive brief alcohol counseling during the 8 weeks of medication treatment. Volunteers ages 13-25 are needed for this study.

Institution
MUSC
Recruitment Contact
Youth Collaborative Intake
843-792-9257
youth@musc.edu

N-Acetylcysteine for Youth Cannabis Use Disorder

Date Added
May 3rd, 2016
PRO Number
Pro00054499
Researcher
Kevin Gray

List of Studies


Keywords
Adolescents, Substance Use
Summary

The purpose of this study is to evaluate the efficacy of the medication N-acetylcysteine (NAC) to help young people quit using marijuana. NAC is an over-the-counter supplement and antioxidant that has been approved by the Food and Drug Administration (FDA) in adults and children for other uses, but has not been approved by the FDA for treatment of marijuana use disorder. Volunteers ages 13-21 are needed for this study.

Institution
MUSC
Recruitment Contact
Intake Team
843-792-9257
youth@musc.edu



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