Trial record 1 of 6 for:
Recruiting Studies | Bipolar II Disorder | United States
Gabapentin for Bipolar & Cannabis Use Disorders
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| ClinicalTrials.gov Identifier: NCT03334721 |
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Recruitment Status :
Recruiting
First Posted : November 7, 2017
Last Update Posted : March 11, 2019
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Sponsor:
Medical University of South Carolina
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
James J. Prisciandaro, Medical University of South Carolina
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Brief Summary:
The proposed 2-week, double-blind, crossover, proof of concept study aims to measure and manipulate core neurochemical (i.e., dysregulated brain GABA/glutamate homeostasis) and neurobehavioral (i.e., elevated impulsivity) dysfunctions characteristic of individuals with cannabis use disorder (CUD) and Bipolar Disorder (BD), using a medication that has been shown to increase cortical GABA (i.e., gabapentin) levels in past research, and to evaluate medication-related changes in response inhibition (go no-go) and cannabis cue reactivity functional Magnetic Resonance Imaging tasks, as well as cannabis use, mood symptoms (including anxiety and sleep), and impulsivity in individuals with CUD+BD.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bipolar I Disorder Bipolar II Disorder Cannabis Use Disorder Substance Use Disorders | Drug: Gabapentin Drug: Placebo Oral Capsule | Phase 2 |
Bipolar disorder (BD) is the Axis I condition most strongly associated with cannabis use disorder (CUD); there is a six-fold increase in the prevalence of CUD in individuals with BD relative to the general population. Individuals with co-occurring CUD and BD (CUD+BD) have substantially worse clinical outcomes than those with either BD or CUD alone. Response to mood stabilizing medications appears to be poor, yet little is known about optimal treatment for CUD+BD, as there have been no randomized medication trials for CUD+BD to date. Convergent evidence supports dysregulated brain γ-Aminobutyric acid (GABA)/glutamate homeostasis as a candidate target for pharmacological intervention in CUD+BD. Preclinical and clinical studies have demonstrated that CUD and BD are each associated with prefrontal GABA and glutamate disturbances and that impulsivity, a core neurobehavioral feature of both CUD and BD and a key Research Domain Criteria (RDoC) construct, is causally related to GABAergic/glutamatergic functioning. Gabapentin has been consistently shown in preclinical research to modulate GABA and glutamate transmission. In human Proton Magnetic Resonance Spectroscopy (1H-MRS) studies, both acute and chronic gabapentin dosing have been shown to increase brain GABA levels, however, few studies have investigated gabapentin effects on glutamate levels. Researchers propose that gabapentin may impact clinical outcomes in CUD+BD individuals both directly and indirectly through their impact on impulsivity.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 23 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Basic Science |
| Official Title: | Gabapentin for Bipolar & Cannabis Use Disorders |
| Actual Study Start Date : | October 1, 2017 |
| Estimated Primary Completion Date : | May 30, 2019 |
| Estimated Study Completion Date : | May 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Gabapentin
Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
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Drug: Gabapentin
5 day trial of gabapentin with titration to 1,200mg |
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Placebo Comparator: Placebo Oral Capsule
Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).
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Drug: Placebo Oral Capsule
5 day trial of matched placebo |
Primary Outcome Measures :
- Prefrontal GABA and glutamate concentrations through Spectroscopy [ Time Frame: Day 5 of each experimental condition ]Concentrations of GABA and glutamate in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy.
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Meets DSM-V criteria for Bipolar Disorder
- Meets DSM-V criteria for Cannabis Use Disorder
- Using at least one mood stabilizing medication
Exclusion Criteria:
- Serious medical or non-inclusionary psychiatric disease
- Concomitant use of benzodiazepine medications or any medications hazardous if taken with gabapentin
- History of clinically significant brain injury
- Presence of non-MRI safe material, or clinically significant claustrophobia.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334721
Contacts
| Contact: James J Prisciandaro, PhD | 843-790-1433 | priscian@musc.edu | |
| Contact: Sara Hix | 843-792-0572 | hixs@musc.edu |
Locations
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: James Prisciandaro, PhD 843-792-1433 | |
| Sub-Investigator: Bryan Tolliver, MD | |
| Sub-Investigator: Anton Raymond, MD | |
| Sub-Investigator: Aimee Mcrae-Clark, MD | |
| Sub-Investigator: Lindsey Squeglia, MD | |
| Sub-Investigator: Will Mellick, PhD | |
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Drug Abuse (NIDA)
Investigators
| Principal Investigator: | James J Prisciandaro, PhD | Medical University of South Carolina |
| Responsible Party: | James J. Prisciandaro, Assistant Professor, Medical University of South Carolina |
| ClinicalTrials.gov Identifier: | NCT03334721 History of Changes |
| Other Study ID Numbers: |
69905 R21DA04391701A1 ( Other Grant/Funding Number: NIDA ) |
| First Posted: | November 7, 2017 Key Record Dates |
| Last Update Posted: | March 11, 2019 |
| Last Verified: | March 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Additional relevant MeSH terms:
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Disease Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Marijuana Abuse Pathologic Processes Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anticonvulsants Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents |