- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03285256
Effects of Repeated Memory Training on Memory Function and Addiction Related Processes
January 8, 2020 updated by: Johns Hopkins University
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.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
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
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins University School of Medicine, Bayview Campus
-
-
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
No
Genders Eligible for Study
All
Description
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
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: Experimental Memory Training
Experimental memory training program
|
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.
|
Active Comparator: Comparator Memory Training 1
Comparator memory training program
|
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.
|
Active Comparator: Comparator Memory Training 2
Alternative comparator memory training program
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in prospective memory over course of training
Time Frame: one month
|
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.
|
one month
|
Change in drug use and substance abuse over course of training.
Time Frame: one month
|
Drug use will be evaluated by urinalysis.
Negative screens are indicative of drug abstinence.
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matthew W Johnson, Ph.D., Johns Hopkins University
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 (Actual)
May 1, 2018
Primary Completion (Actual)
October 1, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
September 8, 2017
First Submitted That Met QC Criteria
September 12, 2017
First Posted (Actual)
September 15, 2017
Study Record Updates
Last Update Posted (Actual)
January 10, 2020
Last Update Submitted That Met QC Criteria
January 8, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00138474
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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