Chronic PainTapProNCT04257695
Developing and Pilot Testing an Opioid Tapering Protocol
A study testing TapPro in people with Chronic Pain and Opioid Use, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
This study proposes to pilot test an intervention to facilitate opioid pain reliever (OPR) tapering in primary care. The intervention will incorporate a clinician embedded within primary care to follow tapering dose schedules to support providers as well to deliver a psychosocial curriculum to support and engage… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opioid Use, Analgesia
- What is being tested?
- TapPro
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2021to 31 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18
- chronic prescription opioid use (>3 monthly prescriptions from the clinic within prior 6 months)
- morphine milligram equivalents (MME) ≥50
- poorly controlled pain (PEG pain score ≥ 5/10)
- providers considering opioid taper but no reductions in opioid dose over the past 6 months.
Who cannot join
- Active cancer or other serious progressive illness, by medical review and by self-report
- Moderate or severe opioid use disorder, as per DSM-V
- Inability to give informed consent
- Active suicidal ideation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Developing and Pilot Testing an Intervention to Increase Opioid Tapering in Primary Care
This study proposes to pilot test an intervention to facilitate opioid pain reliever (OPR) tapering in primary care. The intervention will incorporate a clinician embedded within primary care to follow tapering dose schedules to support providers as well to deliver a psychosocial curriculum to support and engage patients. In a pilot randomized controlled trial (RCT), the study will examine the preliminary efficacy and feasibility of the manualized, protocol-based tapering intervention ("TapPro") compared to usual care. As there is no standard definition or outcome for tapering, the primary efficacy outcome is a decrease in OPR dose over six months. Separately, the study proposes a clinically meaningful dose reduction (greater than or equal to 30 percent) as a secondary outcome. The central hypotheses' are that a tapering intervention with patient and provider support is feasible in a primary care setting and can result in greater dose reduction when compared to usual care.
Read the detailed description
In a 12-week randomized controlled trial based in a primary care outpatient clinic, the study will recruit 60 patients on moderate to high dose chronic opioid therapy for whom providers recommend opioid tapering and randomize 1:1 to an opioid tapering protocolized intervention (TapPro) or to usual care. Over three months, participants in the TapPro arm will visit with a clinician on the telephone on a biweekly basis in order to facilitate opioid prescribing and tapering and a pain self-care and coping curriculum. In the control arm, participants will see their primary care providers as per usual and decisions on opioid prescribing and tapering will be made by the primary care providers. Participants will be assessed throughout the study with questionnaires, urine drug screens, prescription database review, and medical record review.
- Conditions
- Chronic Pain, Opioid Use, Analgesia
- Being tested
- TapPro
- Keywords
- opioid, tapering, chronic pain
- Medical subject headings
- Chronic Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapProBehavioural
Manualized intervention administered by a clinician to facilitate opioid tapering during clinical visits.
| Study group | Role | What they receive |
|---|---|---|
| TapPro | Experimental | Biweekly telephone and in-person visits with a clinician over three months. At each visit, a protocol adapted from the Prescription Opioid Taper Study will be provided to participants, who will learn about pain coping, distraction techniques, diaphragmatic breathing, sleep techniques, and progressive muscle relaxation techniques. All are specifically designed for patients with chronic pain on chronic opioid therapy. During visits, taper parameters will be discussed and the provider will work through a dose reduction schedule, if participants are in agreement. Additionally, urine drug screens will be obtained. Receives: Behavioral: TapPro |
| Usual Care | No intervention | Participants randomized to the usual care arm will continue seeing their primary care providers as indicated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in opioid dose over six months
Repeated measure analysis of opioid dosage over six months
Measured: Up to six months
Secondary outcomes (11)
Opioid dose reduction
Dichotomous outcome assessing whether participant reached a thirty percent or greater opioid dose reduction
Measured: Up to six months
Patient reported pain score
Repeated measure analysis of pain severity, as per the PEG pain screening tool. The PEG is a 3 item scale that assesses pain intensity and interference on a 0 to 10 scale where 0 equals "no pain" and 10 is "pain as bad as you can imagine"
Measured: Up to six months
Pain interference
Repeated measures analysis of pain interference, as per the Brief Pain Inventory (BPI) pain interference subscale. The BPI pain interference subscale is scored as the mean of 7 interference items, scored from 0 (does not interfere) to 10 (completely interferes).
Measured: Up to six months
Pain related self-efficacy
Repeated measures analysis of pain related self-efficacy, as per the Pain Self-Efficacy Scale. The Pain Self-Efficacy scale consists of 10 questions that assess a patient's confidence in performing tasks in spite of pain. It is scored from 0 (not at all confident) to 6 (completely confident). Higher scores are better.
Measured: Up to six months
Change in Quality of life score
Repeated measures analysis of two different quality of life scores, as per the EQ-5D and the Assessment of Quality of Life 8-item scale (AQoL-8D). The EQ-5D measures quality of life in 5 different domains in 5 questions. The AQoL-8D measures quality of life in 8 different domains in 35 questions. Higher scores denote greater quality of life.
Measured: Up to six months
Depressive symptoms
Repeated measures analysis of depression scores, as per the Center for Epidemiologic Studies Depression Scale (CES-D). This is a 20 item questionnaire that assesses the frequency of several depressive symptoms, rated from 0 (rarely or none of the time) to 3 (most or all of the time). Lower scores mean fewer depressive symptoms.
Measured: Up to six months
Anxiety symptoms
Repeated measures analysis of anxiety scores, as per the Brief symptom anxiety subscale. This is a 40 item questionnaire that assesses the frequency of symptoms of anxiety. It is scored from 1 (almost never) to 4 (almost always). Lower scores mean less anxiety.
Measured: Up to six months
Pain catastrophizing
Repeated measures analysis of the Pain Catastrophizing Scale. This is a 13 item scale scored from 0 (not at all) to 4 (all the time) about symptoms associated with pain catastrophizing. Lower scores denote less pain catastrophizing.
Measured: Up to six months
Sleep quality
Repeated measures analysis of sleep quality, as per the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) Sleep Impact Short Form. This is a 5 item survey of sleep symptoms, scored from 1 (always) to 5 (never), with higher scores meaning more problems with sleep.
Measured: Up to six months
Opioid Misuse
Repeated measures analysis of opioid misuse, as per the Current Opioid Misuse Measure (COMM) score. It is a 17 item survey, rated from 0 (never) to 4 (very often), assessing behaviors associated with opioid misuse. Higher scores are associated with greater opioid misuse.
Measured: Up to six months
Opioid Knowledge
Change in Opioid Knowledge score, as per the Survey for Pain Attitudes, Knowledge, and Beliefs (SOPA+KB). This is an 18 question survey that assesses agreement with several pain statements, rated from 1 (do not agree) to 4 (completely agree). Higher scores denote better knowledge.
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start4 May 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Hector Perez, Albert Einstein College of Medicine
- Investigators
- Hector R Perez, MD, MS, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257695
- Sponsor's protocol ID
- 2019-10910
- Other IDs
- K23DA044327, 2019
- Acronym
- TapPro
- Status last verified
- Sep 2023
- First submitted
- 4 Feb 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a pilot study, we have elected to not allow for data to be available to other researchers for secondary analyses.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Pilot Testing an Intervention to Increase Opioid Tapering in Primary Care
- ClinicalTrials.gov ID
- NCT04257695
- Acronym / sponsor ID
- TapPro / 2019-10910
- Conditions
- Chronic Pain, Opioid Use, Analgesia
- Keywords
- opioid, tapering, chronic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 4 May 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 6 Feb 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.
This study proposes to pilot test an intervention to facilitate opioid pain reliever (OPR) tapering in primary care. The intervention will incorporate a clinician embedded within primary care to follow tapering dose schedules to support providers as well to deliver a psychosocial curriculum to support and engage patients. In a pilot randomized controlled trial (RCT), the study will examine the preliminary efficacy and feasibility of the manualized, protocol-based tapering intervention ("TapPro") compared to usual care. As there is no standard definition or outcome for tapering, the primary efficacy outcome is a decrease in OPR dose over six months. Separately, the study proposes a clinically meaningful dose reduction (greater than or equal to 30 percent) as a secondary outcome. The central hypotheses' are that a tapering intervention with patient and provider support is feasible in a primary care setting and can result in greater dose reduction when compared to usual care.
Detailed description
In a 12-week randomized controlled trial based in a primary care outpatient clinic, the study will recruit 60 patients on moderate to high dose chronic opioid therapy for whom providers recommend opioid tapering and randomize 1:1 to an opioid tapering protocolized intervention (TapPro) or to usual care. Over three months, participants in the TapPro arm will visit with a clinician on the telephone on a biweekly basis in order to facilitate opioid prescribing and tapering and a pain self-care and coping curriculum. In the control arm, participants will see their primary care providers as per usual and decisions on opioid prescribing and tapering will be made by the primary care providers. Participants will be assessed throughout the study with questionnaires, urine drug screens, prescription database review, and medical record review.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TapPro | Experimental | Behavioral: TapProBiweekly telephone and in-person visits with a clinician over three months. At each visit, a protocol adapted from the Prescription Opioid Taper Study will be provided to participants, who will learn about pain coping, distraction techniques, diaphragmatic breathing, sleep techniques, and progressive muscle relaxation techniques. All are specifically designed for patients with chronic pain on chronic opioid therapy. During visits, taper parameters will be discussed and the provider will work through a dose reduction schedule, if participants are in agreement. Additionally, urine drug screens will be obtained. |
| Usual Care | No intervention | –Participants randomized to the usual care arm will continue seeing their primary care providers as indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18
- chronic prescription opioid use (>3 monthly prescriptions from the clinic within prior 6 months)
- morphine milligram equivalents (MME) ≥50
- poorly controlled pain (PEG pain score ≥ 5/10)
- providers considering opioid taper but no reductions in opioid dose over the past 6 months.
Key exclusion criteria (4 listed)
- Active cancer or other serious progressive illness, by medical review and by self-report
- Moderate or severe opioid use disorder, as per DSM-V
- Inability to give informed consent
- Active suicidal ideation.
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 |
|---|---|---|
| TapProManualized intervention administered by a clinician to facilitate opioid tapering during clinical visits. | Behavioural | TapPro |
Primary outcome
Change in opioid dose over six months
Time frame: Up to six months
Repeated measure analysis of opioid dosage over six months
11 secondary outcomes
Opioid dose reduction
Time frame: Up to six months
Patient reported pain score
Time frame: Up to six months
Pain interference
Time frame: Up to six months
Pain related self-efficacy
Time frame: Up to six months
Change in Quality of life score
Time frame: Up to six months
Depressive symptoms
Time frame: Up to six months
Anxiety symptoms
Time frame: Up to six months
Pain catastrophizing
Time frame: Up to six months
Sleep quality
Time frame: Up to six months
Opioid Misuse
Time frame: Up to six months
Opioid Knowledge
Time frame: Up to six months
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 13 Sep 2023.
- Individual participant dataSharing planned: No. As this is a pilot study, we have elected to not allow for data to be available to other researchers for secondary analyses.
Related trials for Chronic Pain
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
RecruitingPhase 3
Efficacy and Safety of VER-01 in the Treatment of Participants With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radiculopathy
Recruiting
Light Bulb Stimuli to Reduce Chronic Pain
Fibromyalgia, Musculoskeletal Pain
Active, not recruiting
Probiotics for Inflammation in Pediatric Chronic Pain
Chronic Pain, Body Mass Index >=85th Percentile
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
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.
Hector R Perez, MD, MS principal investigator
Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TapPro in people with Chronic Pain and Opioid Use, run by Albert Einstein College of Medicine 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 4 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 13 Sep 2023. 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 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 opioid dose over six months (time frame: Up to six months). 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 13 Sep 2023.