Neuroscience-Informed Treatment Development for Adolescent Alcohol Use
Condition: Alcohol Drinking; Control
MeSH terms: Alcohol Drinking; Underage Drinking
Intervention: N-Acetylcysteine; Placebo Oral Capsule
Intervention description: N-Acetylcysteine; 600mg capsules by mouth, two pills twice daily (total 2400 mg/day). Participants will undergo MRI (including magnetic resonance imaging and functional MRI during an alcohol cue reactivity task) at baseline, after 10 days of N-Acetylcysteine and after 10 days of placebo.; N-acetylcysteine-matched placebo tablet two pills twice daily. Participants will undergo MRI (including magnetic resonance imaging and functional MRI during an alcohol cue reactivity task) at baseline, after 10 days of N-Acetylcysteine and after 10 days of placebo.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 15 Years
Maximum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: adolescent

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).
    

Eligibility criteria:

        Inclusion criteria: Participants were between the ages of 15-19 and may or may not have
        used alcohol. All participants in the alcohol-using group met criteria for heavy drinking,
        based on quantity and frequency of drinking (Squeglia et al. 2011; Squeglia et al. 2012)
        (see Figure 2).

        Exclusionary criteria: Not having a parent to consent (for those under age 18); history of
        alcohol treatment or treatment-seeking; current DSM-5 diagnosis of moderate or severe
        substance use disorder other than alcohol or cannabis (American Psychiatric Association
        2013); positive urine toxicology screen for narcotics, amphetamines, sedatives, hypnotics,
        or opiates (not prescribed by a doctor); alcohol withdrawal (> 10 on the Clinical Institute
        Withdrawal Assessment for Alcohol (Sullivan et al. 1989); medical conditions or medications
        that contraindicate taking NAC; current use of N-acetylcysteine or any supplement
        containing N-acetylcysteine (must agree not to take any such supplement throughout study
        participation); medical history of severe asthma (uncontrolled with medication); history of
        a serious medical, psychiatric, or neurological problem that could affect neural response,
        brain development, or study participation, including diabetes, seizure disorder, and severe
        head injury with loss of consciousness; history of learning disability, pervasive
        developmental disorder, or other condition requiring special education; current use of
        psychoactive medications that affect cerebral blood flow; non-correctable visual or hearing
        problems; non-fluent in English; MRI contraindications (e.g., braces, claustrophobia,
        irremovable metal implants or piercings); (for females) pregnancy or refusal to use
        reliable methods of birth control; refusal of blood draw, abstinence from alcohol for >14
        days before participation, and use of alcohol <12 hours before scanning (confirmed with
        breathalyzer). While cigarette and marijuana use will not be exclusionary, we will exclude
        any participants who are daily users of cannabis or tobacco.