Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Markus Heilig, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00605904
First received: January 30, 2008
Last updated: May 23, 2012
Last verified: May 2012
Results First Received: September 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Alcoholism
Interventions: Drug: Acamprosate
Drug: Yohimbine
Drug: mCPP
Drug: Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Acamprosate Subjects received 3 tablets of 333mg acamprosate three times daily
Placebo Subjects received 3 tablets of placebo three times daily

Participant Flow for 2 periods

Period 1:   Baseline Data Collection and Dosing
    Acamprosate     Placebo  
STARTED     13 [1]   21 [1]
COMPLETED     13     16  
NOT COMPLETED     0     5  
[1] While 37 subjects were enrolled in the protocol, only 34 were randomized to a study arm

Period 2:   Infusion Sessions
    Acamprosate     Placebo  
STARTED     13     16  
Saline Infusion     13     14  
mCPP Infusion     12     13  
Yohimbine Infusion     12     15 [1]
COMPLETED     12 [2]   13 [2]
NOT COMPLETED     1     3  
[1] Milestones (infusions) were not received in the same order for each subjects so are not consecutive.
[2] Subjects who completed all three types of infusion (given in a different order for each subject)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Acamprosate Subjects received 3 tablets of 333mg acamprosate three times daily
Placebo Subjects received 3 tablets of placebo three times daily
Total Total of all reporting groups

Baseline Measures
    Acamprosate     Placebo     Total  
Number of Participants  
[units: participants]
  13     21     34  
Age  
[units: Participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     13     21     34  
>=65 years     0     0     0  
Gender  
[units: Participants]
     
Female     1     3     4  
Male     12     18     30  
Ethnicity (NIH/OMB)  
[units: Participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     13     20     33  
Unknown or Not Reported     0     1     1  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     3     11     14  
White     9     10     19  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures
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1.  Primary:   Alcohol Craving Rating in Response to Saline Infusion   [ Time Frame: 180 minutes after the start of the infusion ]

2.  Primary:   Alcohol Craving Rating in Response to Meta-Chlorophenylpiperazine   [ Time Frame: 180 minutes after the start of the infusion ]

3.  Primary:   Alcohol Craving Rating in Response to Yohimbine Infusion   [ Time Frame: 180 minutes after the start of the infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Markus Heilig
Organization: NIAAA, NIH
phone: 301.435.9386
e-mail: mheilig@mail.nih.gov


Publications:

Responsible Party: Markus Heilig, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00605904     History of Changes
Other Study ID Numbers: 080058, 08-AA-0058
Study First Received: January 30, 2008
Results First Received: September 21, 2011
Last Updated: May 23, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration