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Effects of GSK598809 on Brain Activation in Abstinent Alcoholics

This study has been terminated.
(Study not approved by BfARM)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00908206
First received: May 21, 2009
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

This study will compare the effects of GSK598809 and placebo in alcohol dependent volunteers. A placebo is a pill with no drug in it (i.e. dummy drug) but it is made to look exactly like the real drug.

Subjects will be given one dose of GSK598809 during one visit and placebo during the other visit. These dosing visits will be at least 1 week apart. The study is randomised, which means that a computer programme will decide by chance (like tossing a coin), the order in which subjects will receive GSK598809 or the placebo, or in other words, whether they will receive GSK598809 or placebo first.

The study is blinded, which means the subjects will not know whether they are receiving study drug or placebo first and neither will the doctors at the institute. If necessary for reasons of safety, the study staff can find out exactly what the subject has received.

The study will last for approximately 4 weeks but could be up to 6 weeks, depending on length of time between screening and dosing. From screening the subjects will be alcohol-abstinent, they may be put on medication for treatment of withdrawal symptoms and then will have at least 7 days without any medication before beginning the study medication. During the study the subjects will be inpatients at the Central Institute of Mental Health. All subjects will be required to fill out questionnaires, perform behavioural tasks and undergo MRI and functional MRI (fMRI) scans.


Condition Intervention Phase
Substance Dependence
Alcohol Dependence
Drug: GSK598809
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Single-blind, Cross-over, Randomised, fMRI Study Comparing Cue-induced Brain Activation Patterns After a Single Oral Dose of GSK598809 or Placebo in Abstinent Alcoholic Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • BOLD signal changes in the relevant brain areas following presentation of visual alcohol-related vs neutral, non-alcohol related cues. [ Time Frame: 1.5h (± 0.5h) after each dose (2 doses) ] [ Designated as safety issue: No ]
  • BOLD signal changes in the same brain structures and circuits as above during a Monetary Incentive Delay task. [ Time Frame: 1.5h (± 0.5h) after each dose (2 doses) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective craving in response to alcohol-related cues measured with the Alcohol Urge Questionnaire (AUQ) and the Obsessive Compulsive Drinking Scale (OCDS). [ Time Frame: Screening and pre-scan. ] [ Designated as safety issue: No ]
  • Spontaneously reported adverse events, laboratory values, cardiovascular variables (blood pressure, heart rate, and ECG variables), temperature, respiratory rate, serum prolactin concentrations, TSH, testosterone, LH and FSH. [ Time Frame: Throughout study. ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters of GSK598809 and its metabolite GSK685249: AUC (0-∞), Cmax, tmax, t½. [ Time Frame: Pre-dose to 48h post dose. ] [ Designated as safety issue: No ]
  • Pair-wise correlation of BOLD signal changes in different image voxels and between selected brain structures during the alcohol-related cue paradigm and the Monetary Incentive Delay task, and in the brain resting state. [ Time Frame: 1.5h (± 0.5h) after each dose (2 doses) ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo to match GSK598809.
Drug: GSK598809
Subjects will receive a single 175 mg oral dose of GSK598809.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alcohol dependent for at least 2 years.
  • Willing to use appropriate contraception method.
  • Weight less than 120 kg.
  • BMI within the range 18.5 - 33 kg/m2.

Exclusion Criteria:

  • Heavy smokers (more than 25 cigarettes per day).
  • Liver cirrhosis.
  • Pregnant or breast feeding female.
  • Psychiatric disorder.
  • Substance dependence or abuse other than alcoholism and nicotine dependence.
  • Medical illness.
  • ECG abnormality (personal or family history).
  • Sudden unexplained death or syncope in first degree relative.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908206

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00908206     History of Changes
Other Study ID Numbers: 109709
Study First Received: May 21, 2009
Last Updated: December 9, 2010
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Keywords provided by GlaxoSmithKline:
Alcoholism
Craving
Dependence
Alcohol

Additional relevant MeSH terms:
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 27, 2014