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Cognitive Stimulation

Primary Purpose

Substance Use Disorders

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Computerized cognitively stimulating activities

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

BPRU, Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adaptive cognitively stimulating activities

Non-adaptive cognitively stimulating activities

Arm Description

Outcomes

Primary Outcome Measures

Working Memory

Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks

Secondary Outcome Measures

Episodic Memory

Trail-making

go/No-go

Addiction Severity Index

Delay Discounting

Digit Symbol Substitution Test

Full Information

NCT ID

NCT01271413

First Posted

January 5, 2011

Last Updated

March 25, 2014

Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT01271413

Brief Title

Cognitive Stimulation

Official Title

Effects of Cognitive Training in Methadone Maintenance Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johns Hopkins University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Use Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

134 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adaptive cognitively stimulating activities

Arm Type

Experimental

Arm Title

Non-adaptive cognitively stimulating activities

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Computerized cognitively stimulating activities

Intervention Description

The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.

Primary Outcome Measure Information:

Title

Working Memory

Description

Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks

Time Frame

baseline, 7 weeks

Secondary Outcome Measure Information:

Title

Episodic Memory

Time Frame

baseline, 7 weeks

Title

Trail-making

Time Frame

baseline, 7 weeks

Title

go/No-go

Time Frame

baseline, 7 weeks

Title

Addiction Severity Index

Time Frame

baseline, 7 weeks

Title

Delay Discounting

Time Frame

baseline, 7 weeks

Title

Digit Symbol Substitution Test

Time Frame

baseline, 7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Miriam Z Mintzer, PhD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

BPRU, Johns Hopkins Bayview Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26404954

Citation

Rass O, Schacht RL, Buckheit K, Johnson MW, Strain EC, Mintzer MZ. A randomized controlled trial of the effects of working memory training in methadone maintenance patients. Drug Alcohol Depend. 2015 Nov 1;156:38-46. doi: 10.1016/j.drugalcdep.2015.08.012. Epub 2015 Aug 24.

Results Reference

derived

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Cognitive Stimulation

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