Glutamatergic Modulation of Disordered Alcohol Use
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 69 |
| Updated: | 6/17/2018 |
| Start Date: | July 2015 |
| End Date: | December 2017 |
The Effect of Brief Potent Glutamatergic Modulation on Disordered Alcohol Use
Alcohol use disorders remain a significant public health problem. The pharmacological
facilitation of behavioral treatment represents a promising strategy for addressing
disordered drinking. Alcohol use disorders are recognized to be associated with various
vulnerabilities that complicate the course of treatment and that may be amenable to glutamate
modulators. The purpose of this randomized, double-blind, controlled trial is to test various
glutamate modulators in conjunction with motivational enhancement therapy (MET) for alcohol
use disorders.
facilitation of behavioral treatment represents a promising strategy for addressing
disordered drinking. Alcohol use disorders are recognized to be associated with various
vulnerabilities that complicate the course of treatment and that may be amenable to glutamate
modulators. The purpose of this randomized, double-blind, controlled trial is to test various
glutamate modulators in conjunction with motivational enhancement therapy (MET) for alcohol
use disorders.
Individuals diagnosed with alcohol dependence will be randomized to receive a single infusion
of glutamate modulators during week 2 while engaged in a 5-week course of MET. They will meet
with staff twice weekly, except for week 2 during which they will present to the clinic three
times. Clinic visits include MET sessions, psychiatric monitoring, assessments, and study
procedures (e.g., medication administration).
of glutamate modulators during week 2 while engaged in a 5-week course of MET. They will meet
with staff twice weekly, except for week 2 during which they will present to the clinic three
times. Clinic visits include MET sessions, psychiatric monitoring, assessments, and study
procedures (e.g., medication administration).
Inclusion Criteria:
- Active alcohol dependence. In the case of the use of other drugs, alcohol is
designated as the primary drug. At least four heavy drinking day over the past 7 days
(>4 drinks a day for males, >3 drinks for females) OR minimum weekly use of 35 drinks
for males and 28 for females
- Physically healthy
- No adverse reactions to study medications
- 21-69 years of age
- Capacity to consent and comply with study procedures, including sufficient proficiency
in English
- Seeking to reduce or stop alcohol use
Exclusion Criteria:
- Meets criteria for current major depression, bipolar disorder, schizophrenia, any
psychotic illness, including substance induced psychosis, and current
substance-induced mood disorder.
- Physiological dependence on another substance requiring medical management, such as
opiods or benzodiazepines, excluding caffeine, nicotine, and cannabis
- Delirium, Dementia, Amnesia, Cognitive Disorders, or Dissociative disorders.
Significant dissociative symptoms
- Current suicide risk or a history of suicide attempt within the past year
- Inability to safely initiate 24 hours of abstinence from alcohol; repeated inability
to initiate abstinence during the trial without incurring significant withdrawal;
history of severe withdrawal phenomena over the past 6 months (e.g.,
withdrawal-related seizure); or self-reported inability to maintain abstinence for 24
hours without substantial distress.
- Pregnant or interested in becoming pregnant during the study period
- Any of the following cardiac conditions: clinically significant left ventricular
hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
- Unstable physical disorders which might make participation hazardous such as end-stage
AIDS, hypertension (>140/90), leukopenia, active hepatitis or other liver disease with
elevated transaminase levels (< 2-3 X upper limit of normal will be considered
acceptable if clotting factors are normal), renal failure, epilepsy, or untreated
diabetes
- Previous history of study medication misuse or abuse, and a history of an adverse
reaction/experience with prior exposure to study medications
- Recent history of significant violence (past 2 years)
- First degree relative with a psychotic disorder (bipolar disorder, schizophrenia,
schizoaffective disorder, or psychosis NOS)
- obesity
- On psychotropic or other medications whose effect could be disrupted by participation
in the study
- BMI > 35
We found this trial at
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