Substance-Related DisordersNCT04404348
Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment
A study testing Cognitive Training in people with Substance-Related Disorders, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
Trial summary
Research has consistently found that cognitive impairment is common in persons with a history of substance abuse. The most commonly identified impairments across all substances are in attentional and working memory functioning and executive functioning; opioid-specific research finds that memory is an additional area… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2020to Dec 2020
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Has completed the detoxification process
- Has completed at least 8 years of formal education
- Speaks and reads English fluently
- Is beginning residential inpatient treatment for opioid abuse (note: may be receiving treatment for polysubstance abuse but opioid must be one of their regular drugs of abuse)
Who cannot join
- Unable to self-consent (has a proxy for medical decision-making, legal guardian, or been otherwise determined unable to give consent)
- Past diagnosis or suspected current diagnosis of a neurodevelopmental disorder (e.g., autism, learning disability), attention-deficit disorder, or neurocognitive disorder (e.g., dementia)
- History of major head trauma (defined as loss of consciousness for 30 minutes or longer) or brain surgery. (Note: History of concussion, including brief loss of consciousness, is okay)
Trial locations and contacts
1 site in 1 country.
About this study
Research has consistently found that cognitive impairment is common in persons with a history of substance abuse. The most commonly identified impairments across all substances are in attentional and working memory functioning and executive functioning; opioid-specific research finds that memory is an additional area of common impairment. Initial research in applying cognitive rehabilitation methods to substance abuse have shown it to be helpful overall.
To develop a cognitive rehabilitation intervention that is effective for opioid abuse, this study will adapt a cognitive training program that has been shown to be effective in other patient groups. Patients in a residential opioid-abuse treatment program will undergo a cognitive evaluation and then be assigned to receive the 4-week cognitive intervention or the 4-week placebo control arm. It is expected that the intervention group will show greater gains on the cognitive post test and will have higher rated treatment adherence and opioid treatment program completion rates.
- Conditions
- Substance-Related Disorders
- Being tested
- Cognitive Training, Placebo Control
- 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.
Cognitive TrainingBehavioural
Also called Posit Science-Brain HQ
Exercises used will be: Mind Bender, Divided Attention, Freeze Frame, Mixed Signals, Target Tracker, To Do List.
Placebo ControlBehavioural
Games are drawn from the set of research control games provided by Posit Science-Brain HQ.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Three times per week for four weeks, participants will complete a computerized cognitive training session (approximately 30 minutes long). Receives: Behavioral: Cognitive Training |
| Control | Placebo comparator | Three times per week for four weeks, participants will complete a computerized session (approximately 30 minutes long) that consists of inert computer games. Receives: Behavioral: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Cognitive Change from Baseline to Endpoint
Change in overall cognitive summary score from pretest to posttest on NIH Toolbox.
Measured: Post-intervention at week 4
Substance Abuse Program Completion Rate
Completion rate of recommended treatment program length, quantified as percentage completed
Measured: Until treatment program discharge, usually 30-45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start6 Mar 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Study halted due to Covid-19 precautions
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia Ford, PhD, Principal investigator, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404348
- Sponsor's protocol ID
- 2018043
- Status last verified
- Sep 2020
- First submitted
- 9 Mar 2020
- Last updated
- 18 Sep 2020
- 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 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04404348
- Acronym / sponsor ID
- 2018043
- Conditions
- Substance-Related Disorders
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study halted due to Covid-19 precautions
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 May 2020 (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.
Research has consistently found that cognitive impairment is common in persons with a history of substance abuse. The most commonly identified impairments across all substances are in attentional and working memory functioning and executive functioning; opioid-specific research finds that memory is an additional area of common impairment. Initial research in applying cognitive rehabilitation methods to substance abuse have shown it to be helpful overall.
To develop a cognitive rehabilitation intervention that is effective for opioid abuse, this study will adapt a cognitive training program that has been shown to be effective in other patient groups. Patients in a residential opioid-abuse treatment program will undergo a cognitive evaluation and then be assigned to receive the 4-week cognitive intervention or the 4-week placebo control arm. It is expected that the intervention group will show greater gains on the cognitive post test and will have higher rated treatment adherence and opioid treatment program completion rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Cognitive TrainingThree times per week for four weeks, participants will complete a computerized cognitive training session (approximately 30 minutes long). |
| Control | Placebo comparator | Behavioral: Placebo ControlThree times per week for four weeks, participants will complete a computerized session (approximately 30 minutes long) that consists of inert computer games. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Has completed the detoxification process
- Has completed at least 8 years of formal education
- Speaks and reads English fluently
- Is beginning residential inpatient treatment for opioid abuse (note: may be receiving treatment for polysubstance abuse but opioid must be one of their regular drugs of abuse)
Key exclusion criteria (3 listed)
- Unable to self-consent (has a proxy for medical decision-making, legal guardian, or been otherwise determined unable to give consent)
- Past diagnosis or suspected current diagnosis of a neurodevelopmental disorder (e.g., autism, learning disability), attention-deficit disorder, or neurocognitive disorder (e.g., dementia)
- History of major head trauma (defined as loss of consciousness for 30 minutes or longer) or brain surgery. (Note: History of concussion, including brief loss of consciousness, is okay)
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 |
|---|---|---|
| Cognitive TrainingAlso: Posit Science-Brain HQExercises used will be: Mind Bender, Divided Attention, Freeze Frame, Mixed Signals, Target Tracker, To Do List. | Behavioural | Intervention |
| Placebo ControlGames are drawn from the set of research control games provided by Posit Science-Brain HQ. | Behavioural | Control |
Primary outcome
Mean Cognitive Change from Baseline to Endpoint
Time frame: Post-intervention at week 4
Change in overall cognitive summary score from pretest to posttest on NIH Toolbox.
Substance Abuse Program Completion Rate
Time frame: Until treatment program discharge, usually 30-45 days
Completion rate of recommended treatment program length, quantified as percentage completed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- 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.
Alicia Ford, PhD principal investigator
Oklahoma State University Center for Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training in people with Substance-Related Disorders, run by Oklahoma State University Center for Health Sciences 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 4 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: paused, as of the sponsor's last update on 18 Sep 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. Some participants in this study may receive a placebo. 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?
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?
Mean Cognitive Change from Baseline to Endpoint (time frame: Post-intervention at week 4). 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 18 Sep 2020.