Trial Outcomes & Findings for Gabapentin for Bipolar & Cannabis Use Disorders (NCT NCT03334721)
NCT ID: NCT03334721
Last Updated: 2020-11-13
Results Overview
Concentrations of GABA, normalized to water and corrected for CSF%, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
Day 5 of each experimental condition
Results posted on
2020-11-13
Participant Flow
Participant milestones
| Measure |
Gabapentin, Then Placebo Oral Capsule
Week 1: 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).
Week 2: 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).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Placebo Oral Capsule: 5 day trial of matched placebo
|
Placebo Oral Capsule, Then Gabapentin
Week 1: 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).
Week 2: 1-week condition will consist of an in-person study visit for assessment and dispensing of Gabapentin medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Placebo Oral Capsule: 5 day trial of matched placebo
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Gabapentin, Then Placebo Oral Capsule
Week 1: 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).
Week 2: 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).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Placebo Oral Capsule: 5 day trial of matched placebo
|
Placebo Oral Capsule, Then Gabapentin
Week 1: 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).
Week 2: 1-week condition will consist of an in-person study visit for assessment and dispensing of Gabapentin medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (days 1-5), MRI (Day 5), and medication washout (Days 5-7).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Placebo Oral Capsule: 5 day trial of matched placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
No longer met inclusion/exclusion criter
|
1
|
0
|
Baseline Characteristics
Gabapentin for Bipolar & Cannabis Use Disorders
Baseline characteristics by cohort
| Measure |
Gabapentin, Then Placebo Oral Capsule
n=12 Participants
Week 1: Gabapentin: 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).
Week 2: Placebo: 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).
|
Placebo Oral Capsule, Then Gabapentin
n=11 Participants
Week 1: Placebo: 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).
Week 2: Gabapentin: 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).
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.58 years
n=5 Participants
|
35.45 years
n=7 Participants
|
37.09 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 5 of each experimental conditionPopulation: Individuals with Bipolar Disorder and Cannabis Use Disorder
Concentrations of GABA, normalized to water and corrected for CSF%, in dorsal anterior cingulate measured via Proton Magnetic Resonance Spectroscopy.
Outcome measures
| Measure |
Gabapentin
n=22 Participants
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).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
|
Placebo Oral Capsule
n=21 Participants
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).
Placebo Oral Capsule: 5 day trial of matched placebo
|
|---|---|---|
|
Prefrontal GABA Concentrations Through Proton Magnetic Resonance Spectroscopy
GABA (randomization order 1, gabapentin 1st)
|
2.625 Institutional Units
Standard Deviation 0.324
|
2.696 Institutional Units
Standard Deviation 0.313
|
|
Prefrontal GABA Concentrations Through Proton Magnetic Resonance Spectroscopy
GABA (randomization order 2, placebo 1st)
|
2.609 Institutional Units
Standard Deviation 0.290
|
2.720 Institutional Units
Standard Deviation 0.248
|
Adverse Events
Gabapentin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo Oral Capsule
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Gabapentin
n=23 participants at risk
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).
Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
|
Placebo Oral Capsule
n=22 participants at risk
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).
Placebo Oral Capsule: 5 day trial of matched placebo
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
4.5%
1/22 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
0.00%
0/22 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/23 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
4.5%
1/22 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
|
General disorders
Fatigue
|
17.4%
4/23 • Number of events 4 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
0.00%
0/22 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
|
Nervous system disorders
Dizziness
|
8.7%
2/23 • Number of events 2 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
0.00%
0/22 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
|
Eye disorders
Blepharospasm
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
0.00%
0/22 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
9.1%
2/22 • Number of events 2 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
|
Metabolism and nutrition disorders
Increased Appetite
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
4.5%
1/22 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
|
Nervous system disorders
Somnolence
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
0.00%
0/22 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
|
Nervous system disorders
Memory Impairment
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
4.5%
1/22 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
|
Musculoskeletal and connective tissue disorders
Abdominal Pain
|
0.00%
0/23 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
4.5%
1/22 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
|
Psychiatric disorders
Insomnia
|
4.3%
1/23 • Number of events 1 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
0.00%
0/22 • Adverse events were collected over a total of 4 visits (Med 1, MRI 1, Med 2, MRI 2) for each participant; 2-weeks.
Please note -23 participants took gabapentin but only 22 took placebo because one participant dropped out of the study prior to receiving the placebo oral capsule (this was a crossover study).
|
Additional Information
James J. Prisciandaro, Ph.D.
Medical University of South Carolina
Phone: 843-792-1433
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place