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Trial record 3 of 4 for:    Miriam Mintzer

Cognitive Stimulation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Miriam Mintzer, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01271413
First received: January 5, 2011
Last updated: March 25, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Substance Use Disorders
Behavioral: Computerized cognitively stimulating activities
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Cognitive Training in Methadone Maintenance Patients

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Working Memory [ Time Frame: baseline, 7 weeks ] [ Designated as safety issue: No ]
    Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks


Secondary Outcome Measures:
  • Episodic Memory [ Time Frame: baseline, 7 weeks ] [ Designated as safety issue: No ]
  • Trail-making [ Time Frame: baseline, 7 weeks ] [ Designated as safety issue: No ]
  • go/No-go [ Time Frame: baseline, 7 weeks ] [ Designated as safety issue: No ]
  • Addiction Severity Index [ Time Frame: baseline, 7 weeks ] [ Designated as safety issue: No ]
  • Delay Discounting [ Time Frame: baseline, 7 weeks ] [ Designated as safety issue: No ]
  • Digit Symbol Substitution Test [ Time Frame: baseline, 7 weeks ] [ Designated as safety issue: No ]

Enrollment: 134
Study Start Date: December 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01271413

Locations
United States, Maryland
BPRU, Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Miriam Z Mintzer, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Miriam Mintzer, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01271413     History of Changes
Other Study ID Numbers: NA_00042772, 1R21DA029708
Study First Received: January 5, 2011
Results First Received: November 23, 2013
Last Updated: March 25, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 24, 2014