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Imaging GABAergic/Glutamatergic Drugs in Bipolar Alcoholics Alcoholics

NCT ID: NCT03220776

Last Updated: 2023-12-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2022-11-21

Brief Summary

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The proposed 3-week, double-blind, crossover, proof of concept study aims to manipulate neurochemical dysfunctions characteristic of individuals with co-occurring BD and AUD (i.e., abnormally low prefrontal GABA and glutamate), using medications that have been shown to normalize cortical GABA (i.e., gabapentin) and glutamate (i.e., NAC) levels in past research, and to evaluate medication-related changes in response inhibition and alcohol cue-reactivity fMRI tasks as well as drinking and mood in individuals with AUD+BD.

Detailed Description

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Bipolar disorder (BD) is the Axis I psychiatric condition most strongly associated with substance use disorder (SUD); diagnostic co-occurrence is particularly high between BD and alcohol use disorder (AUD). Individuals with co-occurring SUD and BD (SUD+BD) have substantially worse clinical outcomes than those with either BD or SUD alone. Nonetheless, little is known about optimal treatment for individuals with SUD+BD; response to lithium appears to be poor, and only one double-blind, randomized, placebo-controlled trial of valproate has demonstrated improved drinking outcomes in this population. Traditionally, treatment trials for SUD+BD have investigated medications that have been FDA approved to treat either BD or SUD in hopes that such medications would prove efficacious in individuals with SUD+BD. A different approach to selecting, and ideally developing, medications for SUD+BD treatment trials would be to target neurochemical dysfunctions characteristic of individuals with both BD and SUD. Recent research by the current investigator has demonstrated unique disturbances in prefrontal gamma-Aminobutyric acid (GABA) and glutamate concentrations in this population using proton magnetic resonance spectroscopy (1H-MRS), with individuals with co-occurring alcohol dependence (AD) and BD having significantly lower levels of GABA and glutamate relative to individuals with BD alone, AD alone, or healthy controls. Lower levels of prefrontal GABA and glutamate were in turn associated with elevated impulsivity and alcohol craving. The proposed 3-week, double-blind, crossover, proof of concept study will evaluate: a) whether medications that have been demonstrated to normalize cortical GABA (i.e., gabapentin) and glutamate (i.e., N-Acetylcysteine \[NAC\]) concentrations in individuals with epilepsy and cocaine dependence, respectively, may similarly act to normalize prefrontal GABA and glutamate levels in individuals with AUD+BD, and b) whether normalization of prefrontal GABA and glutamate levels will be associated with improvements in functional brain activity to tasks that assess core neurobehavioral deficits of AUD and BD (i.e., response inhibition, alcohol cue-reactivity), as well as drinking and mood symptoms. Positive results may support investigation of gabapentin and/or NAC as adjunctive treatments for AUD+BD in large-scale, randomized clinical trials. Most importantly, the proposed study may provide successful demonstration of a neuro-behavioral, multimodal neuroimaging platform for evaluating the potential promise of GABAergic and glutamatergic drugs for AUD and/or BD, as well as other conditions marked by GABAergic/glutamatergic dysfunction.

Conditions

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Alcohol Use Disorder Bipolar Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-Blind

Study Groups

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Gabapentin, then N-Acetylcysteine, then Placebo Oral Capsule

Three, 1-week conditions.

Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Gabapentin: 5 day trial of gabapentin with titration to 1,200mg

Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg

Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Placebo Oral Tablet: 5 day trial of matched placebo

Group Type EXPERIMENTAL

N-Acetylcysteine

Intervention Type DRUG

5 day trial of N-acetylcysteine with titration to 2,400mg

Gabapentin

Intervention Type DRUG

5 day trial of gabapentin with titration to 1,200mg

Placebo Oral Tablet

Intervention Type DRUG

5 day trial of matched placebo

N-Acetylcysteine, then Placebo Oral Capsule, then Gabapentin

3, 1 week conditions.

Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg

Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Placebo Oral Tablet: 5 day trial of matched placebo

Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Gabapentin: 5 day trial of gabapentin with titration to 1,200mg

Group Type EXPERIMENTAL

N-Acetylcysteine

Intervention Type DRUG

5 day trial of N-acetylcysteine with titration to 2,400mg

Gabapentin

Intervention Type DRUG

5 day trial of gabapentin with titration to 1,200mg

Placebo Oral Tablet

Intervention Type DRUG

5 day trial of matched placebo

Placebo Oral Tablet, then Gabapentin, then N-Acetylcysteine

Three, 1-week conditions. Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Placebo Oral Tablet: 5 day trial of matched placebo

Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Gabapentin: 5 day trial of gabapentin with titration to 1,200mg

Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg

Group Type PLACEBO_COMPARATOR

N-Acetylcysteine

Intervention Type DRUG

5 day trial of N-acetylcysteine with titration to 2,400mg

Gabapentin

Intervention Type DRUG

5 day trial of gabapentin with titration to 1,200mg

Placebo Oral Tablet

Intervention Type DRUG

5 day trial of matched placebo

Placebo Oral Capsule, then N-Acetylcysteine, then Gabapentin

Three, 1-week conditions.

Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Placebo Oral Tablet: 5 day trial of matched placebo

Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Gabapentin: 5 day trial of gabapentin with titration to 1,200mg

Group Type EXPERIMENTAL

N-Acetylcysteine

Intervention Type DRUG

5 day trial of N-acetylcysteine with titration to 2,400mg

Gabapentin

Intervention Type DRUG

5 day trial of gabapentin with titration to 1,200mg

Placebo Oral Tablet

Intervention Type DRUG

5 day trial of matched placebo

Gabapentin, then Placebo Oral Capsule, then N-Acetylcysteine

Three, 1-week conditions.

Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Gabapentin: 5 day trial of gabapentin with titration to 1,200mg

Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Placebo Oral Tablet: 5 day trial of matched placebo

Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg

Group Type EXPERIMENTAL

N-Acetylcysteine

Intervention Type DRUG

5 day trial of N-acetylcysteine with titration to 2,400mg

Gabapentin

Intervention Type DRUG

5 day trial of gabapentin with titration to 1,200mg

Placebo Oral Tablet

Intervention Type DRUG

5 day trial of matched placebo

N-Acetylcysteine, then Gabapentin, then Placebo Oral Capsule

Three, 1-week conditions.

Week 1 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 2,400mg N-acetylcysteine) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

N-Acetylcysteine: 5 day trial of N-acetylcysteine with titration to 2,400mg

Week 2 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Gabapentin: 5 day trial of gabapentin with titration to 1,200mg

Week 3 condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Placebo Oral Tablet: 5 day trial of matched placebo

Group Type EXPERIMENTAL

N-Acetylcysteine

Intervention Type DRUG

5 day trial of N-acetylcysteine with titration to 2,400mg

Gabapentin

Intervention Type DRUG

5 day trial of gabapentin with titration to 1,200mg

Placebo Oral Tablet

Intervention Type DRUG

5 day trial of matched placebo

Interventions

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N-Acetylcysteine

5 day trial of N-acetylcysteine with titration to 2,400mg

Intervention Type DRUG

Gabapentin

5 day trial of gabapentin with titration to 1,200mg

Intervention Type DRUG

Placebo Oral Tablet

5 day trial of matched placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Meets DSM-V diagnostic criteria for Bipolar Disorder
* Using at least one mood stabilizing medication
* Meets diagnostic criteria Alcohol Use Disorder, with active drinking in the past month.

Exclusion:

* Serious medical or non-inclusionary psychiatric disease
* Concomitant use of benzodiazepine medications or any medications hazardous if taken with gabapentin/N-acetylcysteine
* History of clinically significant brain injury
* Presence of non-MRI safe material, or clinically significant claustrophobia.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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James J. Prisciandaro

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James J Prisciandarao, Ph. D

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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Document Type: Study Protocol and Statistical Analysis Plan

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R01AA025365

Identifier Type: NIH

Identifier Source: secondary_id

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64964

Identifier Type: -

Identifier Source: org_study_id