Effects of Repeated Memory Training on Memory Function and Addiction Related Processes
Primary Purpose
Substance-Related Disorders
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental memory training
Comparator memory training 1
Comparator memory training 2
Sponsored by
About this trial
This is an interventional treatment trial for Substance-Related Disorders focused on measuring Prospective memory, working memory, substance abuse
Eligibility Criteria
Inclusion Criteria:
- Age 18-55; provision of written consent
- Enrolled in a substance use treatment program
- Sex with ≥ 2 partners in the last 30 days and sex without a condom on at least one occasion in the last year
Exclusion Criteria:
- Severe psychiatric conditions associated with psychosis or any unstable psychiatric condition
- History of medical, psychiatric, or neurological conditions associated with significant cognitive impairment
Sites / Locations
- Johns Hopkins University School of Medicine, Bayview Campus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Experimental Memory Training
Comparator Memory Training 1
Comparator Memory Training 2
Arm Description
Experimental memory training program
Comparator memory training program
Alternative comparator memory training program
Outcomes
Primary Outcome Measures
Change in prospective memory over course of training
Prospective memory will be evaluated within the program itself and measured as the percentage of correct responses within the program. Higher percentages are indicative of greater prospective memory performance.
Change in drug use and substance abuse over course of training.
Drug use will be evaluated by urinalysis. Negative screens are indicative of drug abstinence.
Secondary Outcome Measures
Full Information
NCT ID
NCT03285256
First Posted
September 8, 2017
Last Updated
January 8, 2020
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT03285256
Brief Title
Effects of Repeated Memory Training on Memory Function and Addiction Related Processes
Official Title
Effects of Repeated Memory Training on Memory Function and Addiction Related Processes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit participants before funding period ended.
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective memory is the ability to implement an intention to the future (e.g. remember to take medication, attend a scheduled meeting), and has receive little attention in addiction. The investigators propose that prospective memory plays a critical, yet unrecognized, role in major human behavior change such as that required in addiction treatment. This study will determine the preliminary efficacy of prospective memory training in improving memory and executive functions while reducing illicit drug use in methadone patients. Participants will be randomly assigned to one of three conditions: an experimental memory training program or one of two comparator memory training programs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders
Keywords
Prospective memory, working memory, substance abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to one of three treatment conditions: an experimental memory training program or one of two comparator memory training programs.
Masking
ParticipantInvestigator
Masking Description
Both the participant and the research assistant conducting the assessments will be blinded to group assignment.
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Memory Training
Arm Type
Experimental
Arm Description
Experimental memory training program
Arm Title
Comparator Memory Training 1
Arm Type
Active Comparator
Arm Description
Comparator memory training program
Arm Title
Comparator Memory Training 2
Arm Type
Active Comparator
Arm Description
Alternative comparator memory training program
Intervention Type
Behavioral
Intervention Name(s)
Experimental memory training
Intervention Description
The experimental memory training will be implemented as a computer program that uses state-of-the-art immersive technology to simulate prospective memory in everyday life in which one must remember to carry out tasks throughout the day, while engaging in current ongoing activity. Participants are asked to imagine they have a work-at-home job (ongoing activity), which is an independent program (CogMed QM) designed to train working memory, but that they also need to remember to carry out a number of tasks throughout the day. Using a touch screen, participants will need to touch objects in the simulated environment to appropriately interact with these stimuli according to their pre-assigned tasks.
Intervention Type
Behavioral
Intervention Name(s)
Comparator memory training 1
Intervention Description
The first comparator memory training intervention will utilize the same overall structure and immersive computer environment as the experimental memory intervention, but will not challenge the same aspects of cognition.
Intervention Type
Behavioral
Intervention Name(s)
Comparator memory training 2
Intervention Description
The second comparator memory training intervention will utilize the same overall structure and immersive computer environment as the experimental memory intervention, but will not challenge the same aspects of cognition.
Primary Outcome Measure Information:
Title
Change in prospective memory over course of training
Description
Prospective memory will be evaluated within the program itself and measured as the percentage of correct responses within the program. Higher percentages are indicative of greater prospective memory performance.
Time Frame
one month
Title
Change in drug use and substance abuse over course of training.
Description
Drug use will be evaluated by urinalysis. Negative screens are indicative of drug abstinence.
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-55; provision of written consent
Enrolled in a substance use treatment program
Sex with ≥ 2 partners in the last 30 days and sex without a condom on at least one occasion in the last year
Exclusion Criteria:
Severe psychiatric conditions associated with psychosis or any unstable psychiatric condition
History of medical, psychiatric, or neurological conditions associated with significant cognitive impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew W Johnson, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine, Bayview Campus
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effects of Repeated Memory Training on Memory Function and Addiction Related Processes
We'll reach out to this number within 24 hrs