We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Modulation of Pharmacologically Induced Alcohol Craving in Recently Detoxified Alcoholics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00605904
First Posted: January 31, 2008
Last Update Posted: July 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Markus Heilig, National Institutes of Health Clinical Center (CC)
Results First Submitted: September 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Alcoholism
Interventions: Drug: Acamprosate
Drug: Yohimbine
Drug: mCPP
Drug: Saline

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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 ( Other Identifier: NIH )
First Submitted: January 30, 2008
First Posted: January 31, 2008
Results First Submitted: September 21, 2011
Results First Posted: July 3, 2012
Last Update Posted: July 3, 2012