Testing glutamate modulators for reducing heavy drinking in individuals with alcohol use disorder
The Role of Brief Potent Glutamatergic Modulation in Addressing Problem Drinking: a Randomized, Controlled Trial
This study tests if a new medication that affects brain chemicals can help people with alcohol use disorder drink less, especially when combined with therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 21 Years to 70 Years |
| Sex | All |
| Sponsor | New York State Psychiatric Institute Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04084860 on ClinicalTrials.gov |
What this trial studies
This project investigates the efficacy of glutamate modulators in non-depressed individuals suffering from alcohol use disorder (AUD). The study employs a 2 by 2 factorial design to explore whether the effects of the glutamate modulator are enhanced when combined with behavioral treatments. Participants will be monitored for changes in heavy drinking days compared to an active control group. The research aims to deepen the understanding of glutamate's therapeutic role in treating AUD and provide evidence for this novel pharmacotherapy strategy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21-70 with active alcohol use disorder and a history of heavy drinking.
Not a fit: Patients with current major depression, other substance dependencies, or severe cognitive disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new pharmacological treatment option for individuals struggling with alcohol use disorder.
How similar studies have performed: Previous studies have shown promise in using glutamate modulators for addiction treatment, but this specific approach is still being explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Active alcohol use disorder, with at least 4 heavy drinking day over the past 7 days (greater than 4 drinks a day for males, greater than 3 drinks for females). In the case of the use of other drugs, alcohol is designated as the primary drug 2. Physically healthy 3. No adverse reactions to study medications 4. 21-70 years of age 5. Capacity to consent and comply with study procedures, including sufficient proficiency in English 6. Seeking to reduce or stop alcohol use Exclusion Criteria: 1. Meets DSM IV criteria for current major depression, bipolar disorder, schizophrenia, or any psychotic illness, including substance-induced psychosis 2. Physiological dependence on another substance, such as opioids or benzodiazepines, excluding caffeine, nicotine, and cannabis 3. Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders 4. Current suicide risk or a history of suicide attempt within the past year 5. Inability to safely initiate 24 hours of abstinence from alcohol, as evidenced by CIWA greater than 10 during screening; history of severe withdrawal phenomena over the past 6 months (e.g., inpatient stabilization, withdrawal-related seizure); or self-reported inability to maintain abstinence for 24 hours. 6. Pregnant or interested in becoming pregnant during the study period 7. Any of the following cardiac conditions: clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse 8. Unstable physical disorders which might make participation hazardous such as hypertension (\>160/90), anemia, active hepatitis or other liver disease (transaminase levels \< 2-3 X the upper limit of normal will be considered acceptable), epilepsy, or untreated diabetes. Participants reporting HIV+ status will be asked to provide information about their current treatment, including all medications. Participants who are on the antiretroviral ritonavir (Norvir) will be excluded due to the possibility that study medications in combination with this medication may increase the risk of drug-induced hepatitis. 9. Previous history of misuse or abuse of study medications, and a history of an adverse reaction/experience with prior exposure to study medications 10. Recent history of significant violance 11. On psychotropic or other medications whose effect could be disrupted by participation in the study
Where this trial is running
New York, New York
- Nyspi — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Elias Dakwar, MD — NYSPI/Columbia
- Study coordinator: Kate O'Malley
- Email: kate.omalley@nyspi.columbia.edu
- Phone: 6467746103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.