Substance-Related DisordersNCT03285256
Effects of Repeated Memory Training on Memory Function and Addiction Related Processes
A study testing Experimental memory training, Comparator memory training 1 and Comparator memory training 2 in people with Substance-Related Disorders, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Experimental memory training, Comparator memory training 1 and Comparator memory training 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Severe psychiatric conditions associated with psychosis or any unstable psychiatric condition
- History of medical, psychiatric, or neurological conditions associated with significant cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine, Bayview Campus
Baltimore, Maryland, 21224
About this study
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.
- Conditions
- Substance-Related Disorders
- Being tested
- Experimental memory training, Comparator memory training 1, Comparator memory training 2
- Keywords
- Prospective memory, working memory, substance abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental memory trainingBehavioural
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.
Comparator memory training 1Behavioural
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 2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Memory Training | Experimental | Experimental memory training program Receives: Behavioral: Experimental memory training |
| Comparator Memory Training 1 | Active comparator | Comparator memory training program Receives: Behavioral: Comparator memory training 1 |
| Comparator Memory Training 2 | Active comparator | Alternative comparator memory training program Receives: Behavioral: Comparator memory training 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start1 May 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Why it stopped: Unable to recruit participants before funding period ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew W Johnson, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285256
- Sponsor's protocol ID
- IRB00138474
- Status last verified
- Jan 2020
- First submitted
- 8 Sep 2017
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repeated Memory Training on Memory Function and Addiction Related Processes
- ClinicalTrials.gov ID
- NCT03285256
- Acronym / sponsor ID
- IRB00138474
- Conditions
- Substance-Related Disorders
- Keywords
- Prospective memory, working memory, substance abuse
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit participants before funding period ended.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Memory Training | Experimental | Behavioral: Experimental memory trainingExperimental memory training program |
| Comparator Memory Training 1 | Active comparator | Behavioral: Comparator memory training 1Comparator memory training program |
| Comparator Memory Training 2 | Active comparator | Behavioral: Comparator memory training 2Alternative comparator memory training program |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Severe psychiatric conditions associated with psychosis or any unstable psychiatric condition
- History of medical, psychiatric, or neurological conditions associated with significant cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental memory trainingThe 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. | Behavioural | Experimental Memory Training |
| Comparator memory training 1The 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. | Behavioural | Comparator Memory Training 1 |
| Comparator memory training 2The 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. | Behavioural | Comparator Memory Training 2 |
Primary outcome
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.
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.
Results and safety
The study was stopped early (reason given: Unable to recruit participants before funding period ended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew W Johnson, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental memory training, Comparator memory training 1 and Comparator memory training 2 in people with Substance-Related Disorders, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit participants before funding period ended.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in prospective memory over course of training (time frame: one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020.