Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Neuroscience-Informed Treatment Development for Adolescent Alcohol Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03238300
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Lindsay Squeglia, Medical University of South Carolina

Brief Summary:
This study will examine the effect of N-Acetylcysteine (NAC), an over-the-counter antioxidant supplement, on brains of youth (ages 15-19) using magnetic resonance imaging (MRI). 55 adolescents will receive, in a counterbalanced order, a 10-day course of NAC 1200 mg twice daily and a subsequent 10-day course of matched placebo twice daily, separated by 11 days. Urine and blood samples will be collected at baseline and urine samples again before and after each course of medication treatment. Participants will receive a 1- hour MRI scan at baseline and after each treatment trial.

Condition or disease Intervention/treatment Phase
Alcohol Drinking Control Drug: N-Acetylcysteine Drug: Placebo Oral Capsule Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Neuroscience-Informed Treatment Development for Adolescent Alcohol Use
Actual Study Start Date : October 16, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: N-Acetylcysteine
N-Acetylcysteine 600mg capsules by mouth, two pills twice daily for 10 days.
Drug: N-Acetylcysteine
N-Acetylcysteine pill.

Placebo Comparator: Placebo Oral Capsule
Placebo capsules by mouth, two pills twice daily for 10 days.
Drug: Placebo Oral Capsule
Sugar pill to mimic.




Primary Outcome Measures :
  1. Quantifying the differential effect of N-Acetylcysteine versus placebo on glutamate levels (mmol/kg) in the anterior cingulate brain region. [ Time Frame: 31 days total (levels compared to baseline after 10 days on N-Acetylcysteine and placebo with 11 day washout period in between) ]
    Using magnetic resonance spectroscopy and a within-subjects design, we will determine the effect of N-Acetylcysteine versus placebo on modulating anterior cingulate glutamate levels in adolescents.


Secondary Outcome Measures :
  1. Change in neural reactivity (as measured by BOLD: Blood Oxygen Level-Dependent response) in reward regions during alcohol-cue reactivity task. [ Time Frame: 31 days total (levels compared to baseline after 10 days on N-Acetylcysteine and placebo with 11 day washout period in between) ]
    Assessing the change in neural reactivity to alcohol cues at baseline and after each round of medication: Placebo vs. N-Acetylcysteine.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Please call the site for additional information.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238300


Contacts
Layout table for location contacts
Contact: Lindsay M Squeglia, PhD 843-792-5451 squegli@musc.edu
Contact: Cori A Herring, BA 843-792-8207 herrinco@musc.edu

Locations
Layout table for location information
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Lindsay M Squeglia, PhD    843-792-5451    squegli@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Layout table for investigator information
Principal Investigator: Lindsay M Squeglia, PhD Medical University of South Carolina

Layout table for additonal information
Responsible Party: Lindsay Squeglia, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03238300    
Other Study ID Numbers: Pro00058771
K23AA025399 ( U.S. NIH Grant/Contract )
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lindsay Squeglia, Medical University of South Carolina:
adolescent
Additional relevant MeSH terms:
Layout table for MeSH terms
Alcohol Drinking
Underage Drinking
Drinking Behavior
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes