Can a common nerve pain drug restore brain chemistry in bipolar cannabis users?
NCT ID NCT05064319
First seen Jul 17, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This study tests whether gabapentin, an FDA-approved medication, can help restore the balance of key brain chemicals (GABA and glutamate) in people with bipolar disorder who also use cannabis. Participants are randomly assigned to receive either gabapentin or a placebo for 17 days, and undergo MRI brain scans to measure changes in brain chemistry. The goal is to see if gabapentin can improve brain function in this specific group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gabapentin
- What this could lead to
- If successful, this could point toward a new treatment approach for people with both bipolar disorder and cannabis use disorder.
- What could go wrong
- This is a small, early-phase trial with only 68 participants and a short 17-day treatment period, so results may not apply broadly or show clear benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
51 people
The number who actually took part.
- Started
-
Feb 2022
- Finished
-
Jul 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Medical University Of South Carolina
Charleston, South Carolina, 29425, United States
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