Gabapentin for Bipolar & Cannabis Use Disorders
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ClinicalTrials.gov Identifier: NCT03334721 |
Recruitment Status :
Completed
First Posted : November 7, 2017
Results First Posted : November 13, 2020
Last Update Posted : November 13, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar I Disorder Bipolar II Disorder Cannabis Use Disorder Substance Use Disorders | Drug: Gabapentin Drug: Placebo Oral Capsule | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | Gabapentin for Bipolar & Cannabis Use Disorders |
Actual Study Start Date : | October 1, 2017 |
Actual Primary Completion Date : | July 1, 2019 |
Actual Study Completion Date : | July 1, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Gabapentin, Then Placebo Oral Capsule
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
5 day trial of gabapentin with titration to 1,200mg Drug: Placebo Oral Capsule 5 day trial of matched placebo |
Experimental: Placebo Oral Capsule, Then Gabapentin
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
5 day trial of gabapentin with titration to 1,200mg Drug: Placebo Oral Capsule 5 day trial of matched placebo |
- Prefrontal GABA Concentrations Through Proton Magnetic Resonance Spectroscopy [ Time Frame: Day 5 of each experimental condition ]Concentrations of GABA, normalized to water and corrected for CSF%, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meets DSM-V criteria for Bipolar Disorder
- Meets DSM-V criteria for Cannabis Use Disorder
- Using at least one mood stabilizing medication
Exclusion Criteria:
- Serious medical or non-inclusionary psychiatric disease
- 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.

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): NCT03334721
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | James J Prisciandaro, PhD | Medical University of South Carolina |
Documents provided by James J. Prisciandaro, Medical University of South Carolina:
Responsible Party: | James J. Prisciandaro, Assistant Professor, Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT03334721 |
Other Study ID Numbers: |
69905 R21DA04391701A1 ( Other Grant/Funding Number: NIDA ) |
First Posted: | November 7, 2017 Key Record Dates |
Results First Posted: | November 13, 2020 |
Last Update Posted: | November 13, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Disease Marijuana Abuse Substance-Related Disorders Pathologic Processes Chemically-Induced Disorders Mental Disorders Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anticonvulsants Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents |