Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Medical University of South Carolina
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Is gabapentin generally safe for humans?
Gabapentin has a good safety profile, meaning it is generally safe for humans, and it doesn't require special monitoring or have many drug interactions.
125710What data supports the effectiveness of the drug Gabapentin for treating bipolar disorder?
Research suggests that Gabapentin may help in maintaining stability and treating some symptoms in bipolar patients, as studies have evaluated its use in reducing relapse rates and as an add-on therapy.
24679Will I have to stop taking my current medications?
The trial requires participants to be on a daily mood stabilizing medication, but you cannot take certain medications that interfere with gabapentin, like benzodiazepines or opioids. If you're on any of these, you might need to stop them to join the trial.
How is the drug gabapentin unique for treating bipolar disorder?
Gabapentin is unique for treating bipolar disorder because it is primarily an anti-epileptic drug, but it is being explored as an additional treatment for bipolar symptoms, especially when standard treatments are not effective. It is used as an adjunctive therapy, meaning it is added to existing treatments, and may help with symptoms like mania and depression.
23789Eligibility Criteria
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.Inclusion Criteria
I take a daily mood stabilizer like lithium or lamotrigine.
I am between 18 and 65 years old.
I have a significant problem with cannabis use, tested positive for it, and it's my main substance issue.
Exclusion Criteria
I am not pregnant, breastfeeding, and I use effective birth control.
I am not taking opioids, benzodiazepines, barbiturates, or similar medications.
I am not taking Azelastine, Orphenadrine, Oxomemazine, Paraldehyde, or Thalidomide with Gabapentin.
I have taken gabapentin recently or had a bad reaction to it.
I have not had mental retardation, dementia, or electroconvulsive therapy recently.
My liver enzymes are more than three times the normal level.
My kidney function is low, with creatinine levels more than double the normal range.
I do not have any uncontrolled neurological conditions like epilepsy.
I have had a brain injury where I was unconscious for more than 5 minutes.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A - GabapentinExperimental Treatment1 Intervention
Group II: Group B - PlaceboPlacebo Group1 Intervention
Gabapentin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Neurontin for:
- Postherpetic neuralgia
- Partial-onset seizures
🇪🇺 Approved in European Union as Gabapentin for:
- Peripheral neuropathic pain
- Partial-onset seizures
🇨🇦 Approved in Canada as Gabapentin for:
- Postherpetic neuralgia
- Partial-onset seizures
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Medical University Of South CarolinaCharleston, SC
Loading ...
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
National Institute on Drug Abuse (NIDA)Collaborator
References
Gabapentin: a review of published experience in the treatment of bipolar disorder and other psychiatric conditions. [2019]Successful therapy with valproate and carbamazepine in patients with psychiatric disorders led to investigation of other anticonvulsants for similar indications. Gabapentin is a relatively new anticonvulsant being investigated for potential use in the treatment of bipolar disorder (BD), anxiety disorders, behavioral dyscontrol, and substance use disorders. Its favorable side effect profile, absence of the need for therapeutic drug monitoring, and minimal drug interactions give gabapentin a potential role in these indications. Computer searches of the biomedical literature were undertaken to identify all pertinent case reports, case series, and studies of the drug as monotherapy or adjunctive therapy for BD; 10 reports were retrieved. In the treatment of various anxiety disorders, one study, one case report, and one case series were identified. At least one case series described gabapentin therapy for alcohol withdrawal and one case report of the drug for agitation associated with dementia. Published, well-designed studies evaluating the agent's effectiveness as monotherapy for BD are lacking. Its benefit as an adjunctive treatment with other mood stabilizers is also unestablished. Data regarding its efficacy in the treatment of anxiety disorders or manifestations of substance abuse are limited. These areas may deserve further investigation.
Gabapentin in bipolar disorder: a placebo-controlled trial of adjunctive therapy. Gabapentin Bipolar Disorder Study Group. [2019][corrected] To assess efficacy and safety of gabapentin in the treatment of bipolar disorder.
Gabapentin in the acute treatment of refractory bipolar disorder. [2019]Gabapentin, a new anti-epileptic agent, has been anecdotally reported to be effective in the treatment of mania. We systematically assessed the response rate in bipolar patients being treated adjunctively with gabapentin for manic symptoms, depressive symptoms, or rapid cycling not responsive to standard treatments.
Gabapentin treatment of the non-refractory bipolar spectrum: an open case series. [2019]To determine if gabapentin is effective in monotherapy or add-on treatment of non-refractory bipolar disorder in open prospective treatment.
Gabapentin and methylphenidate treatment of a preadolescent with attention deficit hyperactivity disorder and bipolar disorder. [2018]Gabapentin is an anticonvulsant drug released in the United States in 1993 for use as adjunctive therapy in refractory partial epilepsy. The mechanism of action of gabapentin is unknown, but the drug has very favorable pharmacokinetics and a good safety profile, which allows its use in high-risk patients. Several reports have described the successful use of gabapentin for bipolar disorders in adults, but there are no controlled studies in the use of gabapentin in children and adolescents. We describe a 12-year-old boy with a history of attention deficient hyperactivity disorder (ADHD), reading disorder, mixed receptive and expressive language disorder, encopresis, and bipolar disorder II who was treated with gabapentin 200 mg/day added to methylphenidate 30 mg/day. Within 3 weeks the improvement and stabilization of mood symptoms was remarkable, as noted by mother, teacher, and clinician, and remained so for 6 months of follow-up. Comorbid bipolar disorder and ADHD is a hotly debated topic in the child and adolescent psychiatric literature, with rates of comorbid ADHD and bipolar disorder ranging from 22% to 90%. Controlled studies are needed to evaluate the possible antimanic mood stabilizing and/or antidepressant properties or gabapentin in youths.
Gabapentin treatment for bipolar disorders. [2018][corrected] To review the effectiveness data on the use of gabapentin in bipolar disorders.
[Efficacy of gabapentin in a sample of bipolar patients]. [2018]Field studies support the idea of gabapentin being helpful in the maintenance, and in the treatment of some symptoms in bipolar patients. Our study evaluates relapse rates previous and after gabapentin administration in severe bipolar patients.
Gabapentin augmentation therapy in bipolar depression. [2019]Gabapentin (GBP) may be useful in bipolar disorders, including as adjunctive therapy for bipolar depression, although controlled studies suggest inefficacy as primary treatment for mania or treatment-resistant rapid cycling.
A double-blind, randomized, placebo-controlled, prophylaxis study of adjunctive gabapentin for bipolar disorder. [2019]To conduct the first randomized, controlled trial assessing the prophylactic efficacy of gabapentin in bipolar disorder.
Gabapentin in the treatment of mental illness: the echo chamber of the case series. [2018]Bipolar disorder is a common and debilitating psychiatric illness. Several antiepileptic drugs (AEDs) have been approved for the treatment of bipolar disorder. Gabapentin gained a large market share of AED use in the late 1990s in spite of a lack of randomized clinical trial (RCT) evidence and no labeled indication from the U.S. Food and Drug Administration for its use in psychiatric illness. This article describes the results of a literature review, the purpose of which was to examine the characteristics of studies conducted in humans concerning the efficacy of gabapentin in bipolar disorder.