Cognitive Stimulation

Substance Use Disorders Clinical Trial

Official title:

Effects of Cognitive Training in Methadone Maintenance Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271413
• Other study ID #: NA_00042772
• Secondary ID: 1R21DA029708
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2011
• Last updated: March 25, 2014
• Start date: December 2010
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	BPRU, Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Working Memory	Change in maximum number of digits correctly recalled in Digit Span Backwards task, from baseline to 7 weeks	baseline, 7 weeks	No
Secondary	Episodic Memory		baseline, 7 weeks	No
Secondary	Trail-making		baseline, 7 weeks	No
Secondary	go/No-go		baseline, 7 weeks	No
Secondary	Addiction Severity Index		baseline, 7 weeks	No
Secondary	Delay Discounting		baseline, 7 weeks	No
Secondary	Digit Symbol Substitution Test		baseline, 7 weeks	No