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Galantamine to Enhance Cognitive Behavioral Therapy for Cocaine Abuse

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00809835
First Posted: December 17, 2008
Last Update Posted: June 12, 2017
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University
Results First Submitted: August 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Cocaine Dependence
Interventions: Drug: Galantamine
Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT)

  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
No text entered.

Reporting Groups
  Description
Galantamine and CBT

Drug: Galantamine Daily 8 mg galantamine capsule

Other Names:

Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.

Galantamine Only

Drug: Galantamine Daily 8 mg galantamine capsule

Other Names:

Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine

Placebo and CBT TAU plus computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
Placebo Only Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.

Participant Flow:   Overall Study
    Galantamine and CBT   Galantamine Only   Placebo and CBT   Placebo Only
STARTED   28   27   38   27 
COMPLETED   20   20   27   25 
NOT COMPLETED   8   7   11   2 
Lost to Follow-up                7                6                10                2 
Withdrawal by Subject                1                1                1                0 



  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.
No text entered.

Reporting Groups
  Description
Galantamine and CBT

Drug: Galantamine Daily 8 mg galantamine capsule

Other Names:

Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine

Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research.

Galantamine

Drug: Galantamine Daily 8 mg galantamine capsule

Other Names:

Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine

Placebo and CBT Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
Placebo Only Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
Total Total of all reporting groups

Baseline Measures
   Galantamine and CBT   Galantamine   Placebo and CBT   Placebo Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   27   38   27   120 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.04  (8.72)   38.70  (10.79)   39.82  (8.99)   36.30  (9.41)   38.36  (9.43) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      12  42.9%      15  55.6%      19  50.0%      16  59.3%      62  51.7% 
Male      16  57.1%      12  44.4%      19  50.0%      11  40.7%      58  48.3% 
Race/Ethnicity, Customized 
[Units: Participants]
         
Caucasian   12   15   19   16   62 
African-American   7   6   9   3   25 
Hispanic   9   6   9   8   32 
Multiracial/Other   0   0   1   0   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cocaine Use   [ Time Frame: 12 weeks ]

2.  Primary:   Cocaine Abstinence   [ Time Frame: 12 weeks ]

3.  Secondary:   Cognitive Function   [ Time Frame: 12 weeks ]


  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
No text entered.


  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: Kathleen M. Carroll, Ph.D., Albert E Kent Professor of Psychiatry
Organization: Yale University School of Medicine
phone: 203.937.3486 ext 7403
e-mail: kathleen.carroll@yale.edu



Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00809835     History of Changes
Other Study ID Numbers: 0708002943
R01DA015969-13 ( U.S. NIH Grant/Contract )
First Submitted: December 16, 2008
First Posted: December 17, 2008
Results First Submitted: August 4, 2016
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017