A Phase 4 interventional study of Gabapentin 2g/day divided in two doses for 24 weeks and Placebo 2g/day divided in two doses for 24 weeks in Alcohol Dependence, sponsored by Dayanand Medical College and Hospital. Terminated at 1 site in India. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-13.
Sponsored by Dayanand Medical College and Hospital · Phase 4, Interventional, and Treatment
Alcohol use disorders are present across medical specialties, with alcohol-related deaths particularly prevalent in the categories of injury, liver cirrhosis, cancer, cardiovascular disease, disorders of the peripheral nerves and of the central nervous system. Alcohol dependence, also referred to as alcohol use disorder, is a chronic, relapsing disorder marked by compulsive alcohol use, an inability to stop drinking despite harmful consequences, and the emergence of a withdrawal syndrome upon cessation of use. Early abstinence is associated with activation of brain stress systems in the extended amygdala. Clinically, protracted abstinence involves symptoms of craving, mood and sleep disturbance, all of which have been identified as risk factors for relapse. Nonetheless, implementation of alcohol-specific medications remains limited across most medical specialties. Medications for treating alcohol dependence primarily have been adjunctive interventions, and only three medications-disulfiram, naltrexone, and acamprosate-are approved for this indication by the United States Food and Drug Administration. Baclofen, an inhibitor of synaptic transmission through spinal reflex arcs via hyper polarization of primary afferent fiber terminals, was originally approved by the Food and Drug Administration in 1977 for use in spasticity associated with neurologic conditions, such as multiple sclerosis and spinal cord lesions. However, due to its pharmacologic properties it has also been investigated for the treatment of alcohol dependence. But in the clinical practice of study physicians, it was observed that most of the patients who were prescribed baclofen for alcohol dependence hit back to alcohol very soon despite being on the drug. Therefore there is a need to search for an alternative drug which could be beneficial for this population of patients. Gabapentin is Food and Drug Administration-approved for the management of epileptic seizures and neuropathic pain. It is believed to act by blocking a specific alpha-2d subunit of the voltage-gated calcium channel at selective presynaptic sites and, as a result, to indirectly modulate Gamma Butyric Acid neurotransmission. Pre-clinical findings indicate that gabapentin normalizes the stress-induced Gamma Butyric Acid activation in the amygdala that is associated with alcohol dependence, and provide an excellent pre-clinical rationale for evaluating gabapentin as a treatment for alcohol dependence. Earlier studies of gabapentin in alcohol dependent subjects, attempting to abstain following withdrawal support the safety and potential efficacy of gabapentin in alcohol dependent patients, but definitive conclusions were limited by either small sample size, methodological, or dosing issues.
The study will be conducted on patients with alcohol dependence admitted or coming to the out patient department. The enrolled subjects will be divided into two groups randomly using computer generated randomization system. Informed consent shall be taken from the patient/nearest relative of the patient for enrollment in the trial.
The study will be conducted in 2 independent groups in the ratio of 1:1 (each consisting of 100 patients). By taking the rate of sustained abstinence of 4.1% in placebo and 17% in 1800 mg arm and an odd's ratio of 4.8, the sample size needed is 88 patients in each arm. at 80% power and an alpha level of 0.05. Investigators will use an uncorrected chi-squared statistic to evaluate this null hypothesis.
Study Methods
Enrollment of patients, assessing eligibility and obtaining informed consent will be carried out by one of the study investigators. Breath Test analyzer will be use for detecting the blood alcohol content from the breath sample.
Study Intervention
The patients will be randomized to either
Arm A, Total subjects 100 (Alcoholic liver disease:Alcoholics with no liver disease= 1:1) each will receive Gabapentin 2000mg/day divided in two doses for 24 weeks.
All patients will receive standard of care treatment.
or
Arm B, Total subjects 100 (Alcoholic liver disease: Alcoholics with no liver disease= 1:1)) each will receive Placebo 2000mg/day divided in two doses for 24 weeks.
All patients will receive standard of care treatment.
Concurrent with study medication, study clinicians will provide participants with 20 minutes of weekly manual-guided counseling designed to increase motivation, abstinence, and medication compliance.
Laboratory tests
Hemogram, biochemical tests including blood glucose, liver function tests, prothrombin time, serum electrolytes, blood urea and serum creatinine will be done at baseline and subsequently at the end of 1 month, 3 months and 6 months.
Alcohol Breath Test
All the participants will undergoing alcohol breath-testing at monthly for 6 months. A breath-test will be considered positive if a participant submits a test greater than 0.01% Blood Alcohol Concentration. If a result greater than 0.01% Blood Alcohol Concentration is returned the test will be re-administered (the second testing) 15 minutes after the initial test. A proforma including the date, time of breath-test, breath-test reading and signature and name of person administering the breath-test will be maintained.
Follow-up
All patients will be followed up to 6 months or until death. The status alive or dead will be assessed by telephoning a family member or by contacting the death registry at the patient's birth place or place of residence.
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 25 is below the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Dayanand Medical College and Hospital is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Total subjects 100 (Alcoholic liver disease:Alcoholics with no liver disease= 1:1) each will receive Gabapentin 2g/day divided in two doses for 24 weeks All patient will receive standard of care treatment
Drug: Gabapentin 2g/day divided in two doses for 24 weeks
Total subjects 100 (Alcoholic liver disease: Alcoholics with no liver disease= 1:1)) each will receive Placebo 2g/day divided in two doses for 24 weeks All patient will receive standard of care treatment
Drug: Placebo 2g/day divided in two doses for 24 weeks
Drug page: Gabapentin
Total subjects 100 (Alcoholic liver disease:Alcoholics with no liver disease= 1:1) each will receive Gabapentin 2000mg/day divided in two doses for 24 weeks. All patients will receive standard of care treatment.
Also known as: Gabapentin
Total subjects 100 (Alcoholic liver disease: Alcoholics with no liver disease= 1:1)) each will receive Placebo 2000mg/day divided in two doses for 24 weeks. All patients will receive standard of care treatment. Concurrent with study medication, study clinicians will provide participants with 20 minutes of weekly manual-guided counseling designed to increase motivation, abstinence, and medication compliance.
Also known as: Starch
Rate of no Heavy Episodic Drinking over 6 month.
(Pattern of reduced drinking, described as no heavy episodic drinking. Heavy episodic drinking days are defined by the FDA - National Institute on Alcohol Abuse and Alcoholism (NIAAA) as days when the patient consumes more than four standard drinks (men) or more than three standard drinks (women). Responder analysis will be applied to the rate of Heavy Episodic Drinking.
Time frame: 6 month
Alcohol Craving
Drinking urges were assessed by self-report using the Alcohol Craving Questionnaire-Short Form.
Time frame: 6 month
Change in Quality of Life
Mood was evaluated by self report with the Beck Depression Inventory II
Time frame: 6 month
Change in sleep pattern
Multiple components of sleep disturbance were assessed by self-report using the Pittsburgh Sleep Quality Index
Time frame: 6 month
Rate of Hospital Admission due to alcohol abuse/ decompensation of liver disease
Time frame: 6 month
Change in Gamma-Glutamyl Transferase (GGT) level over the 6 month period
Time frame: 6 month
This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gabapentin
Dayanand Medical College and Hospital