RECRUITING

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

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Conditions

Bipolar DisorderCannabis UseSchizoaffective Disorder, Bipolar TypeBipolar I DisorderBipolar II DisorderCannabis Use Disorder, MildCannabis Use Disorder, ModerateCannabis Use Disorder, Severe

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-02-24
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05064319

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Ages 18-65 years
  2. 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. 3. Meet DSM-5 criteria for bipolar I or II disorder (BD) or Schizoaffective Disorder, Bipolar Type
  4. 4. Able to provide informed consent and read, understand, and accurately complete assessment instruments
  5. 5. Willing to commit to medication treatment and follow-up assessments
  6. 6. Prescribed daily use of at least one mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, carbamazepine, 2nd generation antipsychotic)
  1. 1. A primary psychiatric diagnosis other than BD (e.g., Schizophrenia)
  2. 2. Meet DSM-5 criteria for moderate or severe substance use disorder (other than cannabis or tobacco) within the past 60 days
  3. 3. Any uncontrolled neurological condition (e.g., epilepsy) that could confound the results of the study
  4. 4. Any history of brain injury with loss of consciousness greater than 5 minutes
  5. 5. Any history of mental retardation, dementia, or recent electroconvulsive therapy (in the past 3 months)
  6. 6. Any uncontrolled medical condition that may adversely affect the conduct of the study or jeopardize the safety of the participant
  7. 7. Hepatocellular disease as indicated by plasma levels of liver transaminases (aspartate transaminase, alanine transaminase) greater than 3 times the normal range
  8. 8. Renal insufficiency as indicated by plasma levels of creatinine greater than 2 times the normal range
  9. 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. 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. 11. Azelastine, orphenadrine, oxomemazine, paraldehyde, and thalidomide are generally contraindicated in patients taking gabapentin; as such, individuals taking these medications will be excluded
  12. 12. Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception
  13. 13. Current suicidal or homicidal risk
  14. 14. Baseline scores greater than 35 on the Montgomery-Asberg Depression Rating Scale or greater than 25 on the Young Mania Rating Scale
  15. 15. Has taken gabapentin in the last month or experienced adverse effects/allergic reaction (e.g., angioedema) from it at any time
  16. 16. Significant claustrophobia and/or past negative experiences with MRI
  17. 17. Presence of non-MRI safe materials in the body (e.g., ferrous metal implants, pacemaker)

Contacts and Locations

Study Contact

Sara Hix
CONTACT
843-792-7500
hixs@musc.edu

Principal Investigator

James J Prisciandaro, PhD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

Medical University Of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

  • James J Prisciandaro, PhD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-24
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2022-02-24
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • 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