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Treatment for Alcohol Dependence With Gabapentin (TAG)

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ClinicalTrials.gov Identifier: NCT02771925
Recruitment Status : Unknown
Verified June 2016 by Prof. Sandeep S Sidhu, Dayanand Medical College and Hospital.
Recruitment status was:  Recruiting
First Posted : May 13, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Sandeep S Sidhu, Dayanand Medical College and Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Gabapentin 2g/day divided in two doses for 24 weeks Drug: Placebo 2g/day divided in two doses for 24 weeks Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment for Alcohol Dependence With Gabapentin: A Double Blind Placebo Controlled Randomized Clinical Trial
Study Start Date : June 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: gabapentin
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 Gabapentin 2000mg/day divided in two doses for 24 weeks.

All patients will receive standard of care treatment.

Other Name: Gabapentin

Placebo Comparator: Placebo
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
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.
Other Name: Starch




Primary Outcome Measures :
  1. Rate of no Heavy Episodic Drinking over 6 month. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Alcohol Craving [ Time Frame: 6 month ]
    Drinking urges were assessed by self-report using the Alcohol Craving Questionnaire-Short Form.

  2. Change in Quality of Life [ Time Frame: 6 month ]
    Mood was evaluated by self report with the Beck Depression Inventory II

  3. Change in sleep pattern [ Time Frame: 6 month ]
    Multiple components of sleep disturbance were assessed by self-report using the Pittsburgh Sleep Quality Index

  4. Rate of Hospital Admission due to alcohol abuse/ decompensation of liver disease [ Time Frame: 6 month ]
  5. Change in Gamma-Glutamyl Transferase (GGT) level over the 6 month period [ Time Frame: 6 month ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age more then 18 years
  2. Meet the Diagnostic and Statistical Manual-Fourth Edition (DSM-V) criteria for current alcohol dependence

Exclusion Criteria:

  1. Risk for significant withdrawal based on a Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-AR) score >9
  2. More than one month of abstinence
  3. Dependence on substances other than alcohol
  4. A urine drug screen positive for benzodiazepines or opiates
  5. Clinically significant medical or psychiatric disorders treatment with medications that could affect study outcomes
  6. Treatment mandated by a legal authority

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): NCT02771925


Contacts
Contact: Sandeep S Sidhu, DM +919814025085 sandeepsidhu1963@gmail.com
Contact: Omesh Goyal, DM +919914821155 goyalomesh@yahoo.co.in

Locations
India
Dyanand Medical College and Hospital Recruiting
Ludhiana, Punjab, India, 141001
Contact: Sandeep Singh Sidhu, MD,DM    +919814025085    sandeepsidhu1963@gmail.com   
Contact: Omesh Goyal, MD,DM    +919914821155    goyalomesh@yahoo.co.in   
Principal Investigator: Sandeep Singh Sidhu, MD,DM         
Sponsors and Collaborators
Dayanand Medical College and Hospital
Investigators
Principal Investigator: Sandeep S Sidhu, DM Dayanand Medical College and Hospital, Ludhiana, Punjab, India

Publications of Results:
Responsible Party: Prof. Sandeep S Sidhu, Professor Department of Gastroenterology, Dayanand Medical College and Hospital
ClinicalTrials.gov Identifier: NCT02771925     History of Changes
Other Study ID Numbers: TAG2016
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016

Keywords provided by Prof. Sandeep S Sidhu, Dayanand Medical College and Hospital:
Gabapentin
Alcohol Dependence

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Gabapentin
gamma-Aminobutyric Acid
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents