Opioid UseOABMNCT04436926
Opioid Approach Bias Modification
A study testing opioid approach bias modification in people with Opioid Use and Chronic Pain, run by University of California, San Francisco at 1 site in United States.
Trial summary
To investigate the neurobiological mechanisms underlying opioid approach bias during a pilot RCT of opioid approach bias modification. The investigators are combining novel ultra-high field MRI technology with the promising treatment of modifying cognitive bias away from detrimental prescription drug use will generate… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Opioid Use, Chronic Pain
- What is being tested?
- opioid approach bias modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 30 Nov 2023
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female veterans eligible for VA services
- Ages 18-69
- Chronic pain (current pain lasting ≥ 90 days)
- Prescribed chronic opioids (≥ 90 days in past year)
- High risk for opioid-related averse outcomes (≥ 20mg morphine equivalent daily dose).
Who cannot join
- Psychotic, bipolar disorders or other psychiatric disorders judged to be unstable by the PI
- Current or past history of the following: intrinsic cerebral tumors, cerebrovascular accident/disease, brain aneurysm, arteriovenous malformations, surgical implantation of neurostimulators or cardiac pacemakers, demyelinating and neurodegenerative diseases, penetrating traumatic brain injury, and any other MRI contraindications.
- No female participant will be pregnant or actively attempting to conceive to prevent any unnecessary exposure to high magnetic fields or radio frequency energy to the unborn child.
- Concurrent participation in a treatment study
- Moderately Severe/Severe withdrawal from opioids based on a score of 25 or more on the Clinical Opiate Withdrawal Scale (COWS)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center San Francisco
San Francisco, California, 94121
About this study
Official title: The Neural Basis of Approach Bias Modification in Opioid Users With Chronic Pain
To investigate the neurobiological mechanisms underlying opioid approach bias during a pilot RCT of opioid approach bias modification. The investigators are combining novel ultra-high field MRI technology with the promising treatment of modifying cognitive bias away from detrimental prescription drug use will generate novel neural data and potentially yield a new therapeutic tool to reduce problematic opioid use.
Read the detailed description
The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 6-session (over 2 weeks) clinical trial of opioid approach bias modification (OABM) in 20 male and female veterans with chronic pain at high risk for opioid-related adverse events at the San Francisco Veterans Affairs Health Care System, between ages 18-69. The study consists of screening, 2-week cognitive training, Week-3 post-assessment. Assessment of the neurobiological mechanisms of opioid approach bias will be administered at baseline and Week-3.
- Conditions
- Opioid Use, Chronic Pain
- Being tested
- opioid approach bias modification, sham training
- Keywords
- opioid, approach bias, chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid approach bias modificationBehavioural
The investigators will use a training version of the Approach-Avoidance Task (AAT), in which patients are asked to respond to the format of presented pictures, irrespective of the pictures' content. Pushing a presented picture away will decrease picture size, whereas pulling a picture closer will increase size. There are 2 categories of pictures; 20 different opioid and 20 different non-medication alternative pain managing activities. Training effect is achieved by presenting opioid pictures in push format only and non-opioid pictures in pull format only. Two hundred training trials are presented per session.
sham trainingBehavioural
Sham training is identical to opioid approach bias training, except pictures are presented randomly in both formats.
| Study group | Role | What they receive |
|---|---|---|
| opioid approach bias training | Experimental | Immediately following screening, patients will be randomly assigned to receive 6 sessions of opioid approach bias modification taking place over two weeks. Receives: Behavioral: opioid approach bias modification |
| sham training | Sham comparator | Immediately following screening, patients will be randomly assigned to receive 6 sessions of sham training taking place over two weeks. Receives: Behavioral: sham training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reaction time on an opioid approach-avoidance task across time, baseline to end of treatment, week 3
millisecond reaction time of (opioid push - opioid pull) - (non-opioid push - opioid pull) on an opioid approach-avoidance task where participants are asked to respond to the format of presented pictures, irregardless of the content. There are two categories of pictures; 20 different opioid pictures and 20 different non-opioid pictures, with two-hundred trials. Millisecond reaction time will be measured at baseline, prior to each training session during the 2-week training period, and at week 3 post training assessment. Primary outcome is change in reaction time across time in active vs. sham condition.
Measured: baseline to end of treatment, week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Mar 2021
- Primary completion30 Oct 2023
- Study completion30 Nov 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.
- More trials run by University of California, San FranciscoThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Batki, MD, Principal investigator, University of California, San FranciscoDavid Pennington, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436926
- Sponsor's protocol ID
- 19-29607
- Acronym
- OABM
- Status last verified
- Jun 2024
- First submitted
- 16 Jun 2020
- Last updated
- 14 Jun 2024
- 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 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Basis of Approach Bias Modification in Opioid Users With Chronic Pain
- ClinicalTrials.gov ID
- NCT04436926
- Acronym / sponsor ID
- OABM / 19-29607
- Conditions
- Opioid Use, Chronic Pain
- Keywords
- opioid, approach bias, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 18 Jun 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.
To investigate the neurobiological mechanisms underlying opioid approach bias during a pilot RCT of opioid approach bias modification. The investigators are combining novel ultra-high field MRI technology with the promising treatment of modifying cognitive bias away from detrimental prescription drug use will generate novel neural data and potentially yield a new therapeutic tool to reduce problematic opioid use.
Detailed description
The proposed study is a pilot prospective, parallel groups, randomized, double blind, sham training-controlled, 6-session (over 2 weeks) clinical trial of opioid approach bias modification (OABM) in 20 male and female veterans with chronic pain at high risk for opioid-related adverse events at the San Francisco Veterans Affairs Health Care System, between ages 18-69. The study consists of screening, 2-week cognitive training, Week-3 post-assessment. Assessment of the neurobiological mechanisms of opioid approach bias will be administered at baseline and Week-3.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid approach bias training | Experimental | Behavioral: opioid approach bias modificationImmediately following screening, patients will be randomly assigned to receive 6 sessions of opioid approach bias modification taking place over two weeks. |
| sham training | Sham comparator | Behavioral: sham trainingImmediately following screening, patients will be randomly assigned to receive 6 sessions of sham training taking place over two weeks. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female veterans eligible for VA services
- Ages 18-69
- Chronic pain (current pain lasting ≥ 90 days)
- Prescribed chronic opioids (≥ 90 days in past year)
- High risk for opioid-related averse outcomes (≥ 20mg morphine equivalent daily dose).
Key exclusion criteria (5 listed)
- Psychotic, bipolar disorders or other psychiatric disorders judged to be unstable by the PI
- Current or past history of the following: intrinsic cerebral tumors, cerebrovascular accident/disease, brain aneurysm, arteriovenous malformations, surgical implantation of neurostimulators or cardiac pacemakers, demyelinating and neurodegenerative diseases, penetrating traumatic brain injury, and any other MRI contraindications.
- No female participant will be pregnant or actively attempting to conceive to prevent any unnecessary exposure to high magnetic fields or radio frequency energy to the unborn child.
- Concurrent participation in a treatment study
- Moderately Severe/Severe withdrawal from opioids based on a score of 25 or more on the Clinical Opiate Withdrawal Scale (COWS)
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 |
|---|---|---|
| opioid approach bias modificationThe investigators will use a training version of the Approach-Avoidance Task (AAT), in which patients are asked to respond to the format of presented pictures, irrespective of the pictures' content. Pushing a presented picture away will decrease picture size, whereas pulling a picture closer will increase size. There are 2 categories of pictures; 20 different opioid and 20 different non-medication alternative pain managing activities. Training effect is achieved by presenting opioid pictures in push format only and non-opioid pictures in pull format only. Two hundred training trials are presented per session. | Behavioural | opioid approach bias training |
| sham trainingSham training is identical to opioid approach bias training, except pictures are presented randomly in both formats. | Behavioural | sham training |
Primary outcome
Change in reaction time on an opioid approach-avoidance task across time, baseline to end of treatment, week 3
Time frame: baseline to end of treatment, week 3
millisecond reaction time of (opioid push - opioid pull) - (non-opioid push - opioid pull) on an opioid approach-avoidance task where participants are asked to respond to the format of presented pictures, irregardless of the content. There are two categories of pictures; 20 different opioid pictures and 20 different non-opioid pictures, with two-hundred trials. Millisecond reaction time will be measured at baseline, prior to each training session during the 2-week training period, and at week 3 post training assessment. Primary outcome is change in reaction time across time in active vs. sham condition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- 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.
Steven Batki, MD principal investigator
University of California, San Francisco
David Pennington, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing opioid approach bias modification in people with Opioid Use and Chronic Pain, run by University of California, San Francisco 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 14 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 reaction time on an opioid approach-avoidance task across time, baseline to end of treatment, week 3 (time frame: baseline to end of treatment, week 3). 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 14 Jun 2024.