Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Neuromodulation of Trauma Memories in PTSD & Alcohol Dependence

This study has been completed.
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01055171
First received: January 21, 2010
Last updated: February 8, 2016
Last verified: September 2012
Results First Received: April 18, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Alcohol Dependence
PTSD
Interventions: Drug: Propranolol
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were considered enrolled if they completed both the retrieval and testing procedure (44).

Reporting Groups
  Description
Propranolol

Patients will receive Propranolol in this condition.

Propranolol : 40 mg; Single Administration.

The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).

Placebo

Patient to receive placebo in this condition.

Placebo : 40 mg; Single Dose.

The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)


Participant Flow:   Overall Study
    Propranolol     Placebo  
STARTED     29 [1]   28 [2]
Retrieval Completion     25 [3]   24 [4]
Test Procedure Completion     21 [5]   23 [6]
COMPLETED     18 [7]   21 [8]
NOT COMPLETED     11     7  
[1] Randomized to receive medication.
[2] Randomized to receive placebo.
[3] Received the medication and completed the retrieval session.
[4] Received the sugar pill and completed the retrieval session.
[5] Received the medication and completed the first test session.
[6] Received the placebo and completed the first test session.
[7] Received the medication and completed all visits including the one-week follow-up.
[8] Received the sugar pill and completed all visits including the one-week follow-up.



  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.
Urn randomization was used to assign participants to the propranolol vs. placebo condition while balancing treatment assignment on gender and age (less than 35 or equal to or greater than 35 years of age).

Reporting Groups
  Description
Propranolol

Patients will receive Propranolol in this condition.

Propranolol: 40 mg; Single Administration.

Placebo

Patient to receive placebo in this condition.

Placebo: 40 mg; Single Dose.

Total Total of all reporting groups

Baseline Measures
    Propranolol     Placebo     Total  
Number of Participants  
[units: participants]
  21     23     44  
Age, Customized  
[units: Participants]
     
Greater than or equal to 35 years     14     17     31  
Less than 35 years     7     6     13  
Gender  
[units: Participants]
     
Female     9     13     22  
Male     12     10     22  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Retrieval Session Distress Scores (Session 1)   [ Time Frame: Multiple times throughout cue exposure during retrieval session (Session 1) ]

2.  Primary:   Retrieval Session Craving Scores (Session 1)   [ Time Frame: Multiple times throughout cue exposure during retrieval session (Session 1) ]

3.  Primary:   Test Session Distress Scores (Session 2)   [ Time Frame: Multiple times throughout cue exposure during test session (Session 2) ]

4.  Primary:   Test Session Craving Scores (Session 2)   [ Time Frame: Multiple times throughout cue exposure during test session (Session 2) ]

5.  Secondary:   Proportion of Drinking Days   [ Time Frame: 90 days prior to participation in study up to 2-week follow up session (Session 3) ]


  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
Lack of a “no retrieval” control group. Lack of determination of plasma propranolol levels following the medicated retrieval session. The sample size was insufficient to assess the more distal effects at 1-week follow-up.


  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: Dr. Michael Saladin
Organization: Medical University of South Carolina
phone: 843-792-5306
e-mail: saladinm@musc.edu



Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01055171     History of Changes
Other Study ID Numbers: 19489
1RC1AA019019-01 ( US NIH Grant/Contract Award Number )
Study First Received: January 21, 2010
Results First Received: April 18, 2014
Last Updated: February 8, 2016
Health Authority: United States: Food and Drug Administration