Opioid UseNCT05001789
Cognitive Functioning in Opioid Use Disorder
A study testing CogMed in people with Opioid Use and Cognitive Change, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This outpatient study is designed to examine the potential relationship between non-fatal opioid overdose and cognitive functioning. This study will also examine the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life, drug use). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Use, Cognitive Change, Opioid-use Disorder
- What is being tested?
- CogMed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2021to 30 Jun 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-5 criteria for moderate-severe Opioid Use Disorder (OUD) in the past 6 months
- Enrolled in a suboxone (buprenorphine/naloxone) program; willing to provide consent for research team to contact treatment provider
- History of at least 1 prior opioid overdose
- Recent history of illicit opioid use
- In good physical health
- Access to a smartphone, tablet, or computer
Who cannot join
- Evidence of a co-occurring, untreated psychiatric condition that would make participation risky or difficulty
- Lack of access to a home computer, smartphone, or tablet
- Unable to speak, read and/or communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
NY State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Cognitive Functioning in Opioid Use Disorder: Examining the Impacts of Computerized Working Memory Training and Non-Fatal Opioid Overdose
This outpatient study is designed to examine the potential relationship between non-fatal opioid overdose and cognitive functioning. This study will also examine the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life, drug use). The training component of the study lasts 1 month, with follow up visits and 1-month and 3-months post training.
Read the detailed description
This outpatient study is designed to examine the potential relationship between non-fatal opioid overdose (i.e. overdose that does not result in death), cognitive functioning, and the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life). Participants (n=30) with a history of at least one prior opioid OD, who are enrolled in buprenorphine treatment, will be randomized to 20 sessions of an active (n=15) or sham (n=15) working memory training. Patients will complete measures of cognitive functioning during screening, post-training, and at 1-month and 3-month follow up. Participants will also complete the measures of decision making, psychosocial functioning and drug use at baseline, post-training, and follow up.
- Conditions
- Opioid Use, Cognitive Change, Opioid-use Disorder
- Being tested
- CogMed
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CogMedOther
20 sessions of Cogmed working memory training
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Working memory training with task-difficulty increasing across sessions Receives: Other: CogMed |
| Sham | Active comparator | Working memory training with task-difficulty remaining constant across sessions. Receives: Other: CogMed |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Toolbox Cognition Battery
A brief computerized test of key neuropsychological functions
Measured: Post-Training (1-month from baseline)
NIH Toolbox Cognition Battery
A brief computerized test of key neuropsychological functions
Measured: 1-month Follow up
NIH Toolbox Cognition Battery
A brief computerized test of key neuropsychological functions
Measured: 3-month Follow up
Secondary outcomes (12)
Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)
B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning
Measured: Post-training (1 month from baseline)
Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)
B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning
Measured: 1-month follow up
Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)
B-IPF: scores range from 0 to 49 with higher scores indicating greater difficulties with psychosocial functioning
Measured: 3-month follow up
Illicit Substance Use: Timeline Follow Back (TLFB)
TLFB: measures substance use in the past 1-week period
Measured: Post-training (1-month from baseline)
Illicit Substance Use: Timeline Follow Back (TLFB)
TLFB: measures substance use in the past 1-week period
Measured: 1-month follow up
Illicit Substance Use: Timeline Follow Back (TLFB)
TLFB: measures substance use in the past 1-week period
Measured: 3-month follow up
Quality of Life Scale (QOLS)
QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life
Measured: Post-training (1 month from baseline)
Quality of Life Scale (QOLS)
QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life
Measured: 1-month follow up
Quality of Life Scale (QOLS)
QOLS: scores range from 16 to 112 with higher scores indicating greater quality of life
Measured: 3-month follow up
Impulsive decision making (Delay Discounting Task)
Delay Discounting Task
Measured: Post-training (1 month from baseline)
Impulsive decision making (Delay Discounting Task)
Delay Discounting Task
Measured: 1-month follow up
Impulsive decision making (Delay Discounting Task)
Delay Discounting Task
Measured: 3-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start21 Sep 2021
- Primary completion3 Jun 2024
- Study completion30 Jun 2024
Why it stopped: NYSPI-wide Institutional Research Pause as of June 12, 2023.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra D. Comer, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001789
- Sponsor's protocol ID
- 8185
- Status last verified
- Mar 2025
- First submitted
- 9 Jul 2021
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Functioning in Opioid Use Disorder: Examining the Impacts of Computerized Working Memory Training and Non-Fatal Opioid Overdose
- ClinicalTrials.gov ID
- NCT05001789
- Acronym / sponsor ID
- 8185
- Conditions
- Opioid Use, Cognitive Change, Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: NYSPI-wide Institutional Research Pause as of June 12, 2023.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 12 Aug 2021 (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.
This outpatient study is designed to examine the potential relationship between non-fatal opioid overdose and cognitive functioning. This study will also examine the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life, drug use). The training component of the study lasts 1 month, with follow up visits and 1-month and 3-months post training.
Detailed description
This outpatient study is designed to examine the potential relationship between non-fatal opioid overdose (i.e. overdose that does not result in death), cognitive functioning, and the impact of computerized working memory training on relevant outcomes (cognition, psychosocial functioning, quality of life). Participants (n=30) with a history of at least one prior opioid OD, who are enrolled in buprenorphine treatment, will be randomized to 20 sessions of an active (n=15) or sham (n=15) working memory training. Patients will complete measures of cognitive functioning during screening, post-training, and at 1-month and 3-month follow up. Participants will also complete the measures of decision making, psychosocial functioning and drug use at baseline, post-training, and follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: CogMedWorking memory training with task-difficulty increasing across sessions |
| Sham | Active comparator | Other: CogMedWorking memory training with task-difficulty remaining constant across sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Meets DSM-5 criteria for moderate-severe Opioid Use Disorder (OUD) in the past 6 months
- Enrolled in a suboxone (buprenorphine/naloxone) program; willing to provide consent for research team to contact treatment provider
- History of at least 1 prior opioid overdose
- Recent history of illicit opioid use
- In good physical health
Key exclusion criteria (3 listed)
- Evidence of a co-occurring, untreated psychiatric condition that would make participation risky or difficulty
- Lack of access to a home computer, smartphone, or tablet
- Unable to speak, read and/or communicate in English
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 |
|---|---|---|
| CogMed20 sessions of Cogmed working memory training | Other | Active, Sham |
Primary outcome
NIH Toolbox Cognition Battery
Time frame: Post-Training (1-month from baseline)
A brief computerized test of key neuropsychological functions
NIH Toolbox Cognition Battery
Time frame: 1-month Follow up
A brief computerized test of key neuropsychological functions
NIH Toolbox Cognition Battery
Time frame: 3-month Follow up
A brief computerized test of key neuropsychological functions
12 secondary outcomes
Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)
Time frame: Post-training (1 month from baseline)
Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)
Time frame: 1-month follow up
Psychosocial Functioning (Brief Inventory of Psychosocial Functioning B-IPF)
Time frame: 3-month follow up
Illicit Substance Use: Timeline Follow Back (TLFB)
Time frame: Post-training (1-month from baseline)
Illicit Substance Use: Timeline Follow Back (TLFB)
Time frame: 1-month follow up
Illicit Substance Use: Timeline Follow Back (TLFB)
Time frame: 3-month follow up
Quality of Life Scale (QOLS)
Time frame: Post-training (1 month from baseline)
Quality of Life Scale (QOLS)
Time frame: 1-month follow up
Quality of Life Scale (QOLS)
Time frame: 3-month follow up
Impulsive decision making (Delay Discounting Task)
Time frame: Post-training (1 month from baseline)
Impulsive decision making (Delay Discounting Task)
Time frame: 1-month follow up
Impulsive decision making (Delay Discounting Task)
Time frame: 3-month follow up
Results and safety
The study was stopped early (reason given: NYSPI-wide Institutional Research Pause as of June 12, 2023.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CogMed in people with Opioid Use and Cognitive Change, run by New York State Psychiatric Institute 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 6 inclusion and 3 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 4 Mar 2025. 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: NYSPI-wide Institutional Research Pause as of June 12, 2023.). 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?
NIH Toolbox Cognition Battery (time frame: Post-Training (1-month from baseline)). The study lists 3 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 4 Mar 2025.