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Cognitive Stimulation

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ClinicalTrials.gov Identifier: NCT01271413
Recruitment Status : Completed
First Posted : January 6, 2011
Results First Posted : March 7, 2014
Last Update Posted : April 16, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Miriam Mintzer, Johns Hopkins University

Study Description
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Brief Summary:
This research is being done to learn if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking. The study will compare the effects of different versions of the computer tasks. It also will compare the task performance of different groups of people.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Behavioral: Computerized cognitively stimulating activities Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Cognitive Training in Methadone Maintenance Patients
Study Start Date : December 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Adaptive cognitively stimulating activities Behavioral: Computerized cognitively stimulating activities
The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
Active Comparator: Non-adaptive cognitively stimulating activities Behavioral: Computerized cognitively stimulating activities
The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.


Outcome Measures
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Primary Outcome Measures :
  1. Working Memory [ Time Frame: baseline, 7 weeks ]
    Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks


Secondary Outcome Measures :
  1. Episodic Memory [ Time Frame: baseline, 7 weeks ]
  2. Trail-making [ Time Frame: baseline, 7 weeks ]
  3. go/No-go [ Time Frame: baseline, 7 weeks ]
  4. Addiction Severity Index [ Time Frame: baseline, 7 weeks ]
  5. Delay Discounting [ Time Frame: baseline, 7 weeks ]
  6. Digit Symbol Substitution Test [ Time Frame: baseline, 7 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-55
  • in methadone maintenance or healthy volunteers
  • healthy

Exclusion Criteria:

  • Axis I disorder (except substance abuse and dependence in methadone maintenance patients)
  • severe cognitive impairment
  • serious untreated medical condition
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271413


Locations
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United States, Maryland
BPRU, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Miriam Z Mintzer, PhD Johns Hopkins University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Miriam Mintzer, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01271413    
Other Study ID Numbers: NA_00042772
1R21DA029708 ( U.S. NIH Grant/Contract )
First Posted: January 6, 2011    Key Record Dates
Results First Posted: March 7, 2014
Last Update Posted: April 16, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders