Alcohol DependencePhase 4TAGNCT02771925
Treatment for Alcohol Dependence With Gabapentin
A Phase 4 study testing Gabapentin 2g/day divided in two doses for 24 weeks in people with Alcohol Dependence, run by Dayanand Medical College and Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Gabapentin 2g/day divided in two doses for 24 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2016to 16 May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age more then 18 years
- Meet the Diagnostic and Statistical Manual-Fourth Edition (DSM-V) criteria for current alcohol dependence
Who cannot join
- Risk for significant withdrawal based on a Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-AR) score >9
- More than one month of abstinence
- Dependence on substances other than alcohol
- A urine drug screen positive for benzodiazepines or opiates
- Clinically significant medical or psychiatric disorders treatment with medications that could affect study outcomes
- Treatment mandated by a legal authority
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment for Alcohol Dependence With Gabapentin: A Double Blind Placebo Controlled Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Alcohol Dependence
- Being tested
- Gabapentin 2g/day divided in two doses for 24 weeks, Placebo 2g/day divided in two doses for 24 weeks
- Keywords
- Gabapentin, Alcohol Dependence
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin 2g/day divided in two doses for 24 weeksDrug
Also called 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.
Placebo 2g/day divided in two doses for 24 weeksDrug
Also called Starch
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.
| Study group | Role | What they receive |
|---|---|---|
| gabapentin | Experimental | 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 Receives: Drug: Gabapentin 2g/day divided in two doses for 24 weeks |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo 2g/day divided in two doses for 24 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Secondary outcomes (5)
Alcohol Craving
Drinking urges were assessed by self-report using the Alcohol Craving Questionnaire-Short Form.
Measured: 6 month
Change in Quality of Life
Mood was evaluated by self report with the Beck Depression Inventory II
Measured: 6 month
Change in sleep pattern
Multiple components of sleep disturbance were assessed by self-report using the Pittsburgh Sleep Quality Index
Measured: 6 month
Rate of Hospital Admission due to alcohol abuse/ decompensation of liver disease
Measured: 6 month
Change in Gamma-Glutamyl Transferase (GGT) level over the 6 month period
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startJun 2016
- Primary completion23 Apr 2018
- Study completion16 May 2018
Why it stopped: Due to poor compliance of patients in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dayanand Medical College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Sandeep S Sidhu, Dayanand Medical College and Hospital
- Investigators
- Sandeep S Sidhu, DM, Principal investigator, Dayanand Medical College and Hospital, Ludhiana, Punjab, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771925
- Sponsor's protocol ID
- TAG2016
- Acronym
- TAG
- Status last verified
- Feb 2020
- First submitted
- 18 Apr 2016
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mason BJ, Quello S, Goodell V, Shadan F, Kyle M, Begovic A. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):70-7. doi: 10.1001/jamainternmed.2013.11950.
PubMed 24190578Williams SH. Medications for treating alcohol dependence. Am Fam Physician. 2005 Nov 1;72(9):1775-80.
PubMed 16300039Rehm J, Mathers C, Popova S, Thavorncharoensap M, Teerawattananon Y, Patra J. Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders. Lancet. 2009 Jun 27;373(9682):2223-33. doi: 10.1016/S0140-6736(09)60746-7.
PubMed 19560604Mark TL, Kassed CA, Vandivort-Warren R, Levit KR, Kranzler HR. Alcohol and opioid dependence medications: prescription trends, overall and by physician specialty. Drug Alcohol Depend. 2009 Jan 1;99(1-3):345-9. doi: 10.1016/j.drugalcdep.2008.07.018. Epub 2008 Sep 25.
PubMed 18819759Koob GF. A role for brain stress systems in addiction. Neuron. 2008 Jul 10;59(1):11-34. doi: 10.1016/j.neuron.2008.06.012.
PubMed 18614026
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Alcohol Dependence With Gabapentin: A Double Blind Placebo Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02771925
- Acronym / sponsor ID
- TAG / TAG2016
- Conditions
- Alcohol Dependence
- Keywords
- Gabapentin, Alcohol Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to poor compliance of patients in the study.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dayanand Medical College and HospitalUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gabapentin | Experimental | Drug: Gabapentin 2g/day divided in two doses for 24 weeksTotal 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 |
| Placebo | Placebo comparator | Drug: Placebo 2g/day divided in two doses for 24 weeksTotal 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age more then 18 years
- Meet the Diagnostic and Statistical Manual-Fourth Edition (DSM-V) criteria for current alcohol dependence
Key exclusion criteria (6 listed)
- Risk for significant withdrawal based on a Clinical Institute Withdrawal Assessment-Alcohol, Revised (CIWA-AR) score >9
- More than one month of abstinence
- Dependence on substances other than alcohol
- A urine drug screen positive for benzodiazepines or opiates
- Clinically significant medical or psychiatric disorders treatment with medications that could affect study outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gabapentin 2g/day divided in two doses for 24 weeksAlso: GabapentinTotal 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. | Drug | gabapentin |
| Placebo 2g/day divided in two doses for 24 weeksAlso: StarchTotal 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. | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
Alcohol Craving
Time frame: 6 month
Change in Quality of Life
Time frame: 6 month
Change in sleep pattern
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
Results and safety
The study was stopped early (reason given: Due to poor compliance of patients in the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Results publication: PubMed 24190578Mason BJ, Quello S, Goodell V, Shadan F, Kyle M, Begovic A. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014 Jan;174(1):70-7. doi: 10.1001/jamainternmed.2013.11950.
- Results publication: PubMed 16300039Williams SH. Medications for treating alcohol dependence. Am Fam Physician. 2005 Nov 1;72(9):1775-80.
- Results publication: PubMed 19560604Rehm J, Mathers C, Popova S, Thavorncharoensap M, Teerawattananon Y, Patra J. Global burden of disease and injury and economic cost attributable to alcohol use and alcohol-use disorders. Lancet. 2009 Jun 27;373(9682):2223-33. doi: 10.1016/S0140-6736(09)60746-7.
- Results publication: PubMed 18819759Mark TL, Kassed CA, Vandivort-Warren R, Levit KR, Kranzler HR. Alcohol and opioid dependence medications: prescription trends, overall and by physician specialty. Drug Alcohol Depend. 2009 Jan 1;99(1-3):345-9. doi: 10.1016/j.drugalcdep.2008.07.018. Epub 2008 Sep 25.
- Results publication: PubMed 18614026Koob GF. A role for brain stress systems in addiction. Neuron. 2008 Jul 10;59(1):11-34. doi: 10.1016/j.neuron.2008.06.012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandeep S Sidhu, DM principal investigator
Dayanand Medical College and Hospital, Ludhiana, Punjab, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin 2g/day divided in two doses for 24 weeks in people with Alcohol Dependence, run by Dayanand Medical College and Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to poor compliance of patients in the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of no Heavy Episodic Drinking over 6 month. (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02771925, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.