Neuroscience-Informed Treatment Development for Adolescent Alcohol Use
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|ClinicalTrials.gov Identifier: NCT03238300|
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Drinking Control||Drug: N-Acetylcysteine Drug: Placebo Oral Capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|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|
N-Acetylcysteine 600mg capsules by mouth, two pills twice daily for 10 days.
Placebo Comparator: Placebo Oral Capsule
Placebo capsules by mouth, two pills twice daily for 10 days.
Drug: Placebo Oral Capsule
Sugar pill to mimic.
- 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.
- 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.
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
|Contact: Lindsay M Squeglia, PhDfirstname.lastname@example.org|
|Contact: Cori A Herring, BAemail@example.com|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Lindsay M Squeglia, PhD 843-792-5451 firstname.lastname@example.org|
|Principal Investigator:||Lindsay M Squeglia, PhD||Medical University of South Carolina|