Neuroscience-Informed Treatment Development for Adolescent Alcohol Use

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT03238300

Collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)

Enrollment

Location

Arms

56.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Oct 16, 2017

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Quantifying the differential effect of N-Acetylcysteine versus placebo on glutamate levels (mmol/kg) in the anterior cingulate brain region. [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

Change in neural reactivity (as measured by BOLD: Blood Oxygen Level-Dependent response) in reward regions during alcohol-cue reactivity task. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Please call the site for additional information.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator: Lindsay M Squeglia, PhD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lindsay Squeglia, Assistant Professor, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT03238300

Other Study ID Numbers:

Pro00058771
K23AA025399

First Posted:

Aug 3, 2017

Last Update Posted:

Oct 14, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lindsay Squeglia, Assistant Professor, Medical University of South Carolina

adolescent

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2021