Chronic Low-back PainHOPENCT06931158
HOnest Placebos With Explanations: Evaluating Open-Label Placebos for Chronic Pain
A study testing Standard Rationale and Mindfulness in people with Chronic Low-back Pain and Chronic Pain, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Chronic Low-back Pain, Chronic Pain
- What is being tested?
- Standard Rationale and Mindfulness
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to 19 Jun 2026
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic pain (pain lasting at least 3 months, pain intensity 4/10 or over and interference 3/10 or over)
- at least 18 years old
- English speaking
- have a smartphone or computer with video access
- the chronic pain is concentrated into the patient's lower back (tentative criteria based on recruitment rate)
Who cannot join
- Have chronic pain because of a cancer diagnosis
- Over 89 years of age
- Suspect an allergy to any placebo ingredient
- Currently receiving worker's compensation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02906
About this study
Official title: Optimizing Open Placebos for Chronic Pain Patients
The goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. We also aim to examine the effect of rationale condition on prescription opioid use by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other.
This study will include patients with chronic low back pain. The main question it aims to answer is:
Read more
How do rationales influence the effects of open-label placebos?
Researchers will compare different rationales given when taking an open-label placebo and a no-treatment group and a no rationale group taking OLPs.
Read the detailed description
Further information about study design and hypothesis is provided in the following citation. Study start date refers to the date the first participant completed baseline assessment.
- Conditions
- Chronic Low-back Pain, Chronic Pain
- Being tested
- Open-label Placebo, Standard Rationale, Mindfulness, Control Rationale
- Keywords
- open-label placebo, rationales, placebo effect
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-label PlaceboDrug
Also called OLP, Zeebo
Open-label placebo pill for 21 days at 2 per day
Standard RationaleBehavioural
Scientific rationale about the placebo effect
MindfulnessBehavioural
Mindfulness based rationale
Control RationaleBehavioural
Basic epidemiological information about chronic pain to achieve structural equivalence for the control groups
| Study group | Role | What they receive |
|---|---|---|
| OLP + Standard Rationale | Experimental | Participants in this group will receive an open-label placebo along with information based on the standard rationales used in other OLP studies. Receives: Drug: Open-label Placebo; Behavioral: Standard Rationale |
| OLP + Mindfulness Rationale | Experimental | Participants in this group will receive an open-label placebo along with information with mindfulness information. Receives: Drug: Open-label Placebo; Behavioral: Mindfulness |
| OLP + Control Rationale | Placebo comparator | Participants in this group will receive an open-label placebo along with no information on the placebo effect.. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design. Receives: Drug: Open-label Placebo; Behavioral: Control Rationale |
| No Treatment + Control Rationale | Sham comparator | Participants in this group will receive no treatment. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design. Receives: Behavioral: Control Rationale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Single-item assessing current pain level from 0 (min value) to 10 (max value). Higher scores indicate more pain intensity
Measured: across 42 days
Secondary outcomes (3)
Pain interference
Pain Interference subscale from Brief Pain Inventory Pain interference is measured for general activity, mood, walking ability, work, relationships, sleep, and enjoyment of life on a 0-10 NRS with 0 = "does not interfere" and 10 = "completely interferes" Higher scores indicated greater pain intensity or greater interference with function.
Measured: across 42 days
Pain catastrophizing
Single item assessing how much the patient catastrophizes about their pain from 0 (minimum) to 10 (maximum). Higher scores indicate more catastrophizing.
13 items rated on 5-point Likert scales, from (0) not at all to (4) all the time Higher score indicates higher level of catastrophizing
Item scores are summed into a total score (PCS-T) and three subscale scores:
- Rumination (PCS-R): Items 8, 9, 10, and 11
- Magnification (PCS-M): Items 6, 7, 13
- Helplessness (PCS-H): Items 1, 2, 3, 4, 5, and 12 Minimum total score = 0, maximum total score = 52 Subscale score ranges: PCS-R: 0-16; PCS-M: 0-12; PCS-H: 0-24 A total score above 30 indicates clinically relevant level of catastrophizing
Measured: across 42 days
Prescription Medication use (including opioids)
Measured: across 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start10 Mar 2025
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Bernstein, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931158
- Sponsor's protocol ID
- RIH-2053624-7
- Acronym
- HOPE
- Status last verified
- Jun 2026
- First submitted
- 1 Apr 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Druart L, Lay P, Baird GL, Beaudoin FL, Totten J, Sutherland J, Rosen R, Bernstein MH. Dismantling open-label placebos and their rationales: A remote 4-arm randomized controlled trial protocol. Contemp Clin Trials. 2025 Sep;156:108008. doi: 10.1016/j.cct.2025.108008. Epub 2025 Jul 11.
PubMed 40653310
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Open Placebos for Chronic Pain Patients
- ClinicalTrials.gov ID
- NCT06931158
- Acronym / sponsor ID
- HOPE / RIH-2053624-7
- Conditions
- Chronic Low-back Pain, Chronic Pain
- Keywords
- open-label placebo, rationales, placebo effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 17 Apr 2025 (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.
The goal of this clinical trial is to examine the effect of rationale condition when taking open-label placebos on pain by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other. We also aim to examine the effect of rationale condition on prescription opioid use by 1) comparing each rationale to the no rationale control condition and the no treatment control condition; and 2) comparing the rationale conditions to each other.
This study will include patients with chronic low back pain. The main question it aims to answer is:
How do rationales influence the effects of open-label placebos?
Researchers will compare different rationales given when taking an open-label placebo and a no-treatment group and a no rationale group taking OLPs.
Detailed description
Further information about study design and hypothesis is provided in the following citation. Study start date refers to the date the first participant completed baseline assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| OLP + Standard Rationale | Experimental | Drug: Open-label Placebo, Behavioral: Standard RationaleParticipants in this group will receive an open-label placebo along with information based on the standard rationales used in other OLP studies. |
| OLP + Mindfulness Rationale | Experimental | Drug: Open-label Placebo, Behavioral: MindfulnessParticipants in this group will receive an open-label placebo along with information with mindfulness information. |
| OLP + Control Rationale | Placebo comparator | Drug: Open-label Placebo, Behavioral: Control RationaleParticipants in this group will receive an open-label placebo along with no information on the placebo effect.. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design. |
| No Treatment + Control Rationale | Sham comparator | Behavioral: Control RationaleParticipants in this group will receive no treatment. They will receive basic epidemiological information on chronic pain to guarantee structural equivalence of the trial design. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- chronic pain (pain lasting at least 3 months, pain intensity 4/10 or over and interference 3/10 or over)
- at least 18 years old
- English speaking
- have a smartphone or computer with video access
- the chronic pain is concentrated into the patient's lower back (tentative criteria based on recruitment rate)
Key exclusion criteria (4 listed)
- Have chronic pain because of a cancer diagnosis
- Over 89 years of age
- Suspect an allergy to any placebo ingredient
- Currently receiving worker's compensation.
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 |
|---|---|---|
| Open-label PlaceboAlso: OLP, ZeeboOpen-label placebo pill for 21 days at 2 per day | Drug | OLP + Control Rationale, OLP + Mindfulness Rationale, OLP + Standard Rationale |
| Standard RationaleScientific rationale about the placebo effect | Behavioural | OLP + Standard Rationale |
| MindfulnessMindfulness based rationale | Behavioural | OLP + Mindfulness Rationale |
| Control RationaleBasic epidemiological information about chronic pain to achieve structural equivalence for the control groups | Behavioural | No Treatment + Control Rationale, OLP + Control Rationale |
Primary outcome
Pain intensity
Time frame: across 42 days
Single-item assessing current pain level from 0 (min value) to 10 (max value). Higher scores indicate more pain intensity
3 secondary outcomes
Pain interference
Time frame: across 42 days
Pain catastrophizing
Time frame: across 42 days
Prescription Medication use (including opioids)
Time frame: across 42 days
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 23 Jul 2026.
- Derived from this study: PubMed 40653310Druart L, Lay P, Baird GL, Beaudoin FL, Totten J, Sutherland J, Rosen R, Bernstein MH. Dismantling open-label placebos and their rationales: A remote 4-arm randomized controlled trial protocol. Contemp Clin Trials. 2025 Sep;156:108008. doi: 10.1016/j.cct.2025.108008. Epub 2025 Jul 11.
- 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.
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 Standard Rationale and Mindfulness in people with Chronic Low-back Pain and Chronic Pain, run by Rhode Island Hospital 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 23 Jul 2026. 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?
Pain intensity (time frame: across 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06931158, which also lists 1 linked publication.
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 23 Jul 2026.