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Gamma-Aminobutyric Acid (GABA) Analog

Gabapentin for Bipolar Disorder

Phase 2
Recruiting
Led By James J Prisciandaro, PhD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prescribed daily use of at least one mood stabilizing medication (i.e., lithium, divalproex sodium, lamotrigine, carbamazepine, 2nd generation antipsychotic)
Ages 18-65 years
Must not have
Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception
Concomitant use of opioid medications, benzodiazepines, barbiturates, chloral hydrate, sodium oxybate, or any other medication deemed to be hazardous if taken with gabapentin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of treatment, approximately 17 days

Summary

This trial will study the effects of Gabapentin on people with Bipolar Disorder who use marijuana. They will take the medication or a placebo for 17 days, and have 5 study visits with 2 MRI brain scans.

Who is the study for?
Adults aged 18-65 with bipolar disorder and moderate to severe cannabis use disorder, who are already on mood stabilizers, can join this study. They must be willing to take medication and attend follow-ups. Exclusions include certain medical conditions, recent electroconvulsive therapy, pregnancy or inadequate contraception use, high risk of suicide or homicide, past negative reactions to gabapentin or MRI scans.
What is being tested?
The trial is testing Gabapentin against a placebo in people with bipolar disorder who also smoke marijuana. Over 17 days, participants will take the assigned treatment and undergo brain scans (MRI), questionnaires, interviews, and side effect monitoring during five visits.
What are the potential side effects?
Potential side effects from Gabapentin may include dizziness, sleepiness, water retention leading to swelling in limbs, difficulty walking normally; however specific side effects for this trial will be consistently assessed at each visit.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I take a daily mood stabilizer like lithium or lamotrigine.
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I am between 18 and 65 years old.
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I have a significant problem with cannabis use, tested positive for it, and it's my main substance issue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, breastfeeding, and I use effective birth control.
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I am not taking opioids, benzodiazepines, barbiturates, or similar medications.
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I am not taking Azelastine, Orphenadrine, Oxomemazine, Paraldehyde, or Thalidomide with Gabapentin.
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I have taken gabapentin recently or had a bad reaction to it.
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I have not had mental retardation, dementia, or electroconvulsive therapy recently.
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My liver enzymes are more than three times the normal level.
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My kidney function is low, with creatinine levels more than double the normal range.
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I do not have any uncontrolled neurological conditions like epilepsy.
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I have had a brain injury where I was unconscious for more than 5 minutes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of treatment, approximately 17 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of treatment, approximately 17 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Weight Changes

Side effects data

From 2021 Phase 4 trial • 88 Patients • NCT03012815
2%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gabapentin
Benzodiazepine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A - GabapentinExperimental Treatment1 Intervention
Group II: Group B - PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gabapentin
2013
Completed Phase 4
~1550

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
979 Previous Clinical Trials
7,400,897 Total Patients Enrolled
10 Trials studying Bipolar Disorder
211 Patients Enrolled for Bipolar Disorder
National Institute on Drug Abuse (NIDA)NIH
2,606 Previous Clinical Trials
3,329,896 Total Patients Enrolled
16 Trials studying Bipolar Disorder
1,610 Patients Enrolled for Bipolar Disorder
James J Prisciandaro, PhDPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
23 Total Patients Enrolled
1 Trials studying Bipolar Disorder
23 Patients Enrolled for Bipolar Disorder

Media Library

Gabapentin (Gamma-Aminobutyric Acid (GABA) Analog) Clinical Trial Eligibility Overview. Trial Name: NCT05064319 — Phase 2
Bipolar Disorder Research Study Groups: Group A - Gabapentin, Group B - Placebo
Bipolar Disorder Clinical Trial 2023: Gabapentin Highlights & Side Effects. Trial Name: NCT05064319 — Phase 2
Gabapentin (Gamma-Aminobutyric Acid (GABA) Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05064319 — Phase 2
~24 spots leftby Jun 2026
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