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Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05064319
Recruitment Status : Recruiting
First Posted : October 1, 2021
Last Update Posted : July 8, 2022
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
James J. Prisciandaro, Medical University of South Carolina

Brief Summary:
This research study evaluates the effects of an FDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be assigned to take either Gabapentin or a matched placebo. Study medication will be taken for 17 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Cannabis Use Schizoaffective Disorder, Bipolar Type Bipolar I Disorder Bipolar II Disorder Cannabis Use Disorder, Mild Cannabis Use Disorder, Moderate Cannabis Use Disorder, Severe Drug: Gabapentin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders: A Randomized, Double-blind, Placebo-controlled, Parallel-group, MRI Study
Actual Study Start Date : February 24, 2022
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
Experimental: Group A - Gabapentin Drug: Gabapentin
After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive gabapentin 2-3 times a day for a total of 17 days.

Placebo Comparator: Group B - Placebo Drug: Placebo
After group assignment but before taking any study medication, and again 17 days later, participants will have a Magnetic Resonance Imaging (MRI) exam after completing various assessments (clinical interview, questionnaires, etc.). Group A will receive placebo 2-3 times a day for a total of 17 days.




Primary Outcome Measures :
  1. Change in prefrontal GABA concentrations through Proton Magnetic Resonance Spectroscopy [ Time Frame: Baseline to end of treatment, approximately 17 days ]
    Concentrations of GABA, normalized to water and corrected for CSF%, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy.



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  1. Ages 18-65 years
  2. Meet DSM-5 criteria for moderate or severe cannabis use disorder (CUD; within the past 3 months), provide a positive urine cannabinoid screen at baseline, and identify cannabis as the primary substance of abuse
  3. Meet DSM-5 criteria for bipolar I or II disorder (BD) or Schizoaffective Disorder, Bipolar Type
  4. Able to provide informed consent and read, understand, and accurately complete assessment instruments
  5. Willing to commit to medication treatment and follow-up assessments
  6. Prescribed daily use of at least one mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, carbamazepine, 2nd generation antipsychotic)

Exclusion Criteria:

  1. A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)
  2. Meet DSM-5 criteria for moderate or severe substance use disorder (other than cannabis or tobacco) within the past 60 days
  3. Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study
  4. Any history of brain injury with loss of consciousness greater than 5 minutes
  5. Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)
  6. Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant
  7. Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range
  8. Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range
  9. Concomitant use of medications that could interfere with glutamatergic/GABAergic transmission (e.g., benzodiazepines, ceftriaxone, riluzole, memantine, ketamine, topiramate, vigabatrin), due to potential confounding effects
  10. Concomitant use of opioid medications, benzodiazepines, barbiturates, chloral hydrate, sodium oxybate, or any other medication deemed to be hazardous if taken with gabapentin
  11. Azelastine, orphenadrine, oxomemazine, paraldehyde, and thalidomide are generally contraindicated in patients taking gabapentin; as such, individuals taking these medications will be excluded
  12. Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception
  13. Current suicidal or homicidal risk
  14. Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale
  15. Has taken gabapentin in the last month or experienced adverse effects/allergic reaction (e.g., angioedema) from it at any time
  16. Significant claustrophobia and/or past negative experiences with MRI
  17. Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)

Information from the National Library of Medicine

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): NCT05064319


Contacts
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Contact: Sara Hix 843-792-7500 hixs@musc.edu

Locations
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United States, South Carolina
Medical University Of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Sara Hix    843-792-0572    hixs@musc.edu   
Principal Investigator: James J Prisciandaro, PhD         
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: James J Prisciandaro, PhD Medical University of South Carolina
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Responsible Party: James J. Prisciandaro, Associate Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT05064319    
Other Study ID Numbers: 00112593
R01DA054275 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2021    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Disease
Marijuana Abuse
Bipolar Disorder
Psychotic Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Schizophrenia Spectrum and Other Psychotic 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