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New treatment option for Bipolar Disorder
Official title Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders
ClinicalTrials.gov ID: NCT05064319
What this study is testing
What is Gabapentin?
Gabapentin is an investigational medicine, being studied as a potential treatment for bipolar disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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)
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.