Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
Primary Purpose
Bipolar Disorder, Cannabis Use, Schizoaffective Disorder, Bipolar Type
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
Inclusion Criteria:
- Ages 18-65 years
- 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
- Meet DSM-5 criteria for bipolar I or II disorder (BD) or Schizoaffective Disorder, Bipolar Type
- Able to provide informed consent and read, understand, and accurately complete assessment instruments
- Willing to commit to medication treatment and follow-up assessments
- Prescribed daily use of at least one mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, carbamazepine, 2nd generation antipsychotic)
Exclusion Criteria:
- A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)
- Meet DSM-5 criteria for moderate or severe substance use disorder (other than cannabis or tobacco) within the past 60 days
- Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study
- Any history of brain injury with loss of consciousness greater than 5 minutes
- Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)
- Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant
- Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range
- Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range
- 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
- Concomitant use of opioid medications, benzodiazepines, barbiturates, chloral hydrate, sodium oxybate, or any other medication deemed to be hazardous if taken with gabapentin
- Azelastine, orphenadrine, oxomemazine, paraldehyde, and thalidomide are generally contraindicated in patients taking gabapentin; as such, individuals taking these medications will be excluded
- Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception
- Current suicidal or homicidal risk
- Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale
- Has taken gabapentin in the last month or experienced adverse effects/allergic reaction (e.g., angioedema) from it at any time
- Significant claustrophobia and/or past negative experiences with MRI
- Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)
Sites / Locations
- Medical University Of South CarolinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A - Gabapentin
Group B - Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in 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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05064319
First Posted
September 22, 2021
Last Updated
July 20, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05064319
Brief Title
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A - Gabapentin
Arm Type
Experimental
Arm Title
Group B - Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Change in prefrontal GABA concentrations through Proton Magnetic Resonance Spectroscopy
Description
Concentrations of GABA, normalized to water and corrected for CSF%, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy.
Time Frame
Baseline to end of treatment, approximately 17 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ages 18-65 years
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
Meet DSM-5 criteria for bipolar I or II disorder (BD) or Schizoaffective Disorder, Bipolar Type
Able to provide informed consent and read, understand, and accurately complete assessment instruments
Willing to commit to medication treatment and follow-up assessments
Prescribed daily use of at least one mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, carbamazepine, 2nd generation antipsychotic)
Exclusion Criteria:
A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)
Meet DSM-5 criteria for moderate or severe substance use disorder (other than cannabis or tobacco) within the past 60 days
Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study
Any history of brain injury with loss of consciousness greater than 5 minutes
Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)
Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant
Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range
Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range
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
Concomitant use of opioid medications, benzodiazepines, barbiturates, chloral hydrate, sodium oxybate, or any other medication deemed to be hazardous if taken with gabapentin
Azelastine, orphenadrine, oxomemazine, paraldehyde, and thalidomide are generally contraindicated in patients taking gabapentin; as such, individuals taking these medications will be excluded
Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception
Current suicidal or homicidal risk
Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale
Has taken gabapentin in the last month or experienced adverse effects/allergic reaction (e.g., angioedema) from it at any time
Significant claustrophobia and/or past negative experiences with MRI
Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Hix
Phone
843-792-7500
Email
hixs@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James J Prisciandaro, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Hix
Phone
843-792-0572
Email
hixs@musc.edu
First Name & Middle Initial & Last Name & Degree
James J Prisciandaro, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
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