NCT03285256

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

1.4 years

First QC Date

September 8, 2017

Last Update Submit

January 8, 2020

Conditions

Keywords

Prospective memory, working memory, substance abuse

Outcome Measures

Primary Outcomes (2)

  • 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.

    one month

  • 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.

    one month

Study Arms (3)

Experimental Memory Training

EXPERIMENTAL

Experimental memory training program

Behavioral: Experimental memory training

Comparator Memory Training 1

ACTIVE COMPARATOR

Comparator memory training program

Behavioral: Comparator memory training 1

Comparator Memory Training 2

ACTIVE COMPARATOR

Alternative comparator memory training program

Behavioral: Comparator memory training 2

Interventions

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.

Experimental Memory Training

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.

Comparator Memory Training 1

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.

Comparator Memory Training 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Severe psychiatric conditions associated with psychosis or any unstable psychiatric condition
  • History of medical, psychiatric, or neurological conditions associated with significant cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine, Bayview Campus

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Matthew W Johnson, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Both the participant and the research assistant conducting the assessments will be blinded to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of three treatment conditions: an experimental memory training program or one of two comparator memory training programs.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 15, 2017

Study Start

May 1, 2018

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations