Gabapentin for Bipolar & Cannabis Use Disorders

NCT03334721 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 69905R21DA04391701A1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed 2-week, double-blind, crossover, proof of concept study aims to measure and manipulate core neurochemical (i.e., dysregulated brain GABA/glutamate homeostasis) and neurobehavioral (i.e., elevated impulsivity) dysfunctions characteristic of individuals with cannabis use disorder (CUD) and Bipolar Disorder (BD), using a medication that has been shown to increase cortical GABA (i.e., gabapentin) levels in past research, and to evaluate medication-related changes in response inhibition (go no-go) and cannabis cue reactivity functional Magnetic Resonance Imaging tasks, as well as cannabis use, mood symptoms (including anxiety and sleep), and impulsivity in individuals with CUD+BD.

Conditions

Bipolar I Disorder; Bipolar II Disorder; Cannabis Use Disorder; Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Prefrontal GABA Concentrations Through Proton Magnetic Resonance Spectroscopy

  Concentrations of GABA, normalized to water and corrected for CSF%, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy.

  Day 5 of each experimental condition

Study Arms (2)

Gabapentin, Then Placebo Oral Capsule

EXPERIMENTAL

Week 1: 1-week 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). Week 2: 1-week 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).

Drug: Gabapentin; Drug: Placebo Oral Capsule

Placebo Oral Capsule, Then Gabapentin

EXPERIMENTAL

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

Drug: Gabapentin; Drug: Placebo Oral Capsule

Interventions

Gabapentin DRUG

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

Gabapentin, Then Placebo Oral Capsule; Placebo Oral Capsule, Then Gabapentin

Placebo Oral Capsule DRUG

5 day trial of matched placebo

Gabapentin, Then Placebo Oral Capsule; Placebo Oral Capsule, Then Gabapentin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM-V criteria for Bipolar Disorder
• Meets DSM-V criteria for Cannabis Use Disorder
• Using at least one mood stabilizing medication

You may not qualify if:

• Concomitant use of benzodiazepine medications or any medications hazardous if taken with gabapentin
• History of clinically significant brain injury
• Presence of non-MRI safe material, or clinically significant claustrophobia.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Prisciandaro JJ, Mellick W, Squeglia LM, Hix S, Arnold L, Tolliver BK. Results from a randomized, double-blind, placebo-controlled, crossover, multimodal-MRI pilot study of gabapentin for co-occurring bipolar and cannabis use disorders. Addict Biol. 2022 Jan;27(1):e13085. doi: 10.1111/adb.13085. Epub 2021 Aug 14.

  PMID: 34390300 DERIVED

MeSH Terms

Conditions

Bipolar Disorder; Substance-Related Disorders

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: James J. Prisciandaro, Ph.D.
• Organization: Medical University of South Carolina

priscian@musc.edu

843-792-1433

Study Officials

• James J Prisciandaro, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: November 7, 2017
• Study Start: October 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: November 13, 2020
• Results First Posted: November 13, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)