NCT02349477

Brief Summary

This treatment study is a 16-weeks outpatient clinical trial where subjects with alcohol dependence will get medication, which might help them to reduce or stop their drinking, or a placebo ( placebo is a capsule that looks the same as the investigational drug, but has no real medication. It is a "sugar pill").

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 4, 2019

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

3.8 years

First QC Date

January 15, 2015

Results QC Date

August 29, 2019

Last Update Submit

October 15, 2019

Conditions

Alcohol Use DisorderAlcohol Withdrawal

Outcome Measures

Primary Outcomes (1)

  • Percent of Subjects With no Heavy Drinking Days (PSNHDD)

    The primary dependent variable will be the percent of subjects with no heavy drinking days (4 or more standard drinks for women and 5 or more standard drinks for men). Participants will report their daily alcohol use with using a daily calendar. No heavy drinking days is corrected for %dCDT.

    4 months

Secondary Outcomes (1)

  • Percent of Subjects With no Drinking Days (PSNDD)

    4 months

Other Outcomes (1)

  • Number of Participants With No Drinking Days by AWS Score and Medication

    4 months

Study Arms (2)

Gabapentin

EXPERIMENTAL

Gabapentin up to 1200 mg per day in 3 divided doses

Drug: Gabapentin

placebo

PLACEBO COMPARATOR

matching placebo

Drug: Placebo

Interventions

GabapentinDRUG

gaba potentiating medication

Also known as: neurontin
Gabapentin
PlaceboDRUG

a pill that looks exactly like the active medication but does not contain medication

Also known as: Sugar Pill
placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets criteria for alcohol use disorder based on DSM-5 criteria
  • Meets criteria for history of alcohol withdrawal based on DSM-5 criteria
  • Able to maintain abstinence for a minimum of 3 days prior to randomization as verified by self report, urine ETG, and breathalyzer.

You may not qualify if:

  • Significant psychiatric or medical illness
  • No other substance abuse
  • Taking other medications known to treat alcohol use disorder
  • Unstable living arrangements
  • Significant legal problems pending

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (3)

  • Hoffman M, Voronin K, Book SW, Prisciandaro J, Bristol EJ, Anton RF. Sleep as an Important Target or Modifier in Alcohol Use Disorder Clinical Treatment: Example From a Recent Gabapentin Randomized Clinical Trial. J Addict Med. 2024 Sep-Oct 01;18(5):520-525. doi: 10.1097/ADM.0000000000001316. Epub 2024 May 31.

    PMID: 38828963DERIVED

  • Prisciandaro JJ, Hoffman M, Brown TR, Voronin K, Book S, Bristol E, Anton RF. Effects of Gabapentin on Dorsal Anterior Cingulate Cortex GABA and Glutamate Levels and Their Associations With Abstinence in Alcohol Use Disorder: A Randomized Clinical Trial. Am J Psychiatry. 2021 Sep 1;178(9):829-837. doi: 10.1176/appi.ajp.2021.20121757. Epub 2021 Jul 14.

    PMID: 34256607DERIVED

  • Anton RF, Latham P, Voronin K, Book S, Hoffman M, Prisciandaro J, Bristol E. Efficacy of Gabapentin for the Treatment of Alcohol Use Disorder in Patients With Alcohol Withdrawal Symptoms: A Randomized Clinical Trial. JAMA Intern Med. 2020 May 1;180(5):728-736. doi: 10.1001/jamainternmed.2020.0249.

    PMID: 32150232DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

GabapentinSugars

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsCarbohydrates

Results Point of Contact

Title
Dr. Michaela Hoffman
Organization
Medical University of South Carolina
HoffmaMi@musc.edu
8437927758

Study Officials

  • Raymond F Anton, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2015

First Posted

January 29, 2015

Study Start

November 1, 2014

Primary Completion

August 27, 2018

Study Completion

August 27, 2018

Last Updated

November 4, 2019

Results First Posted

November 4, 2019

Record last verified: 2019-10

Locations

US(1)