Cognitive Stimulation

March 25, 2014 updated by: Miriam Mintzer, Johns Hopkins University

Effects of Cognitive Training in Methadone Maintenance Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • BPRU, Johns Hopkins Bayview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Episodic Memory
Time Frame: baseline, 7 weeks
baseline, 7 weeks
Trail-making
Time Frame: baseline, 7 weeks
baseline, 7 weeks
go/No-go
Time Frame: baseline, 7 weeks
baseline, 7 weeks
Addiction Severity Index
Time Frame: baseline, 7 weeks
baseline, 7 weeks
Delay Discounting
Time Frame: baseline, 7 weeks
baseline, 7 weeks
Digit Symbol Substitution Test
Time Frame: baseline, 7 weeks
baseline, 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Miriam Z Mintzer, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

January 5, 2011

First Submitted That Met QC Criteria

January 5, 2011

First Posted (Estimate)

January 6, 2011

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

March 25, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00042772
  • 1R21DA029708 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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