Opioid-use DisorderNCT05121428
Patients' Attitudes Toward and Experiences With Buprenorphine Treatment
An observational study of Opioid-use Disorder and Acceptability of Health Care, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
This study will disseminate five surveys collecting individual's attitudes and experiences during buprenorphine treatment for Opioid Use Disorder during the COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder, Acceptability of Health Care, Opioid-Related Disorders
- How many people
- 817 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2021to 20 Mar 2027
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subject population consists of adults aged 18+ who live in Massachusetts and are currently prescribed buprenorphine by a healthcare provider to treat OUD. Those under the age of 18 will be screened out of the investigation during the consent process. In addition, because many of the survey questions used in this investigation are based on established survey instruments that were created in the English language and validated among English-speaking participants, we will limit the subject population or this study to English-speaking adults.
Who may be able to join
- Participants must be 18 years of age or older.
- Participants report currently having a legal prescription for buprenorphine for opioid use disorder.
- Participants must have a past or present opioid use disorder.
- Participants must currently reside in the state of Massachusetts.
- Participants must be able to comprehend the English language.
Who cannot join
- Unable to complete an online survey.
- Unable to complete a verification step that ensures bots are not used to complete survey.
- Complete a survey with no variation suggesting they did not read the survey.
Trial locations and contacts
1 site in 1 country.
United States1 site
CHA Center for Mindfulness and Compassion
Cambridge, Massachusetts, 02141
About this study
Official title: Exploring the Attitudes and Experiences of Patients Engaged in Buprenorphine Treatment During the COVID-19 Pandemic
This study will disseminate five surveys collecting individual's attitudes and experiences during buprenorphine treatment for Opioid Use Disorder during the COVID-19 pandemic.
Read the detailed description
The primary objective of this study is to better understand patients' attitudes and experiences during office-based opioid treatment (OBOT) in the COVID-19 pandemic. This study specifically aims to evaluate attitudes and experiences of people prescribe buprenorphine across five domains with the hope of evaluating a) whether telemedicine has improved their access to and experiences with OBOT; b) the factors that motivate individuals in OBOT to abstain from opioid drug use; c) how patients' view the use of cannabis, benzodiazepines, and nicotine during OBOT; d) the degree to which patients in OBOT report using cannabis, benzodiazepines, and nicotine and how their use might have changed during the COVID-19 pandemic; and e) whether patients attitudes towards cannabis, benzodiazepines, and cigarettes/e-cigarettes are associated with their use of those same substances.
- Keywords
- Opioid Use Disorder, Substance Use Disorders, Buprenorphine, Suboxone, Cannabis, Cigarettes, E-Cigarettes, Benzodiazepines, Healthcare, COVID-19, Telemedicine, Office-Based Opioid Treatment, Facebook, Social Media, Nicotine, Recovery
- Medical subject headings
- Opioid-Related Disorders, Patient Acceptance of Health Care, Substance-Related Disorders, Marijuana Abuse, Vaping, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Survey 1 | Survey investigating patients' experiences with buprenorphine treatment for Opioid Use Disorder before and during the COVID-19 pandemic | |
| Survey 2 | Survey investigating the factors that motivate patients to abstain from opioid drug use during buprenorphine treatment for Opioid Use Disorder | |
| Survey 3 | Survey investigating patients' attitudes towards and experiences with cannabis use during buprenorphine treatment for Opioid Use Disorder. | |
| Survey 4 | Survey investigating patients' attitudes towards and experiences with cigarettes and e-cigarettes use during buprenorphine treatment for Opioid Use Disorder. | |
| Survey 5 | Survey investigating patients' attitudes towards and experiences with benzodiazepine use during buprenorphine treatment for Opioid Use Disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's Experiences with Office-Based Opioid Treatment
This is an eight-item scale that measures the degree to which participants report being able to access buprenorphine treatment-related appointments and medications before and during the COVID-19 pandemic. Participants will be asked to rate each of the eight questions on a 7-point Likert scale from 1 = "extremely easy" to 7= "extremely difficult."
Measured: Day 1
Reasons for Abstaining from Opioids Questionnaire
This 17-item scale will measure participant ratings of the importance of 17 factors that motivate abstinence from illicit drug use during office-based opioid treatment. Participants will be asked to rate each of these 17 items on a scale from 0 = "not at all important" to 4 = "extremely important."
Measured: Day 1
Patients' Attitudes Toward the Use of Cannabis During Office-Based Opioid Treatment
Participants will rate three items on a scale of 1 = "completely disagree" to 7 = "completely agree." Specifically, participants will rate the degree to which they feel cannabis use is acceptable during office-based opioid treatment (OBOT), they believe that their prescribers' feel cannabis use is acceptable during OBOT, and they feel comfortable discussing cannabis use with their buprenorphine prescribers.
Measured: Day 1
Patients' Attitudes Toward the Use of Cigarettes/E-Cigarettes During Office-Based Opioid Treatment
Participants will rate three items on a scale of 1 = "completely disagree" to 7 = "completely agree." Specifically, participants will rate the degree to which patients should be encouraged to quit smoking cigarettes and e-cigarette during office-based opioid treatment (OBOT) and the degree to which they feel smoking helps manage cravings during OBOT.
Measured: Day 1
Patients' Attitudes Toward and Experiences with the Use of Benzodiazepines during Office-Based Opioid Treatment
Participants will rate three items on a scale of 1 = "completely disagree" to 7 = "completely agree." Specifically, participants will rate the degree to which benzodiazepine use is acceptable during office-based opioid treatment (OBOT), they feel OBOT providers find benzodiazepine use by their patients acceptable, and they feel comfortable openly discussing their benzodiazepine use with their buprenorphine prescriber.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start20 Nov 2021
- Primary completion20 Mar 2025
- Study completion20 Mar 2027 (estimated)
Why it stopped: Study completed Phase 1 before funding ended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 817 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Zev Schuman-Olivier, MD, Principal investigator, Cambridge Health AllianceJoseph Rosansky, Study director, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121428
- Sponsor's protocol ID
- CHA-IRB-1179/03/21
- Other IDs
- 3R33AT010125, R01CA229355
- Status last verified
- Jun 2025
- First submitted
- 21 Oct 2021
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Attitudes and Experiences of Patients Engaged in Buprenorphine Treatment During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05121428
- Acronym / sponsor ID
- CHA-IRB-1179/03/21
- Keywords
- Opioid Use Disorder, Substance Use Disorders, Buprenorphine, Suboxone, Cannabis, Cigarettes, E-Cigarettes, Benzodiazepines
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study completed Phase 1 before funding ended.
- Enrolment
- 817 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 16 Nov 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 study will disseminate five surveys collecting individual's attitudes and experiences during buprenorphine treatment for Opioid Use Disorder during the COVID-19 pandemic.
Detailed description
The primary objective of this study is to better understand patients' attitudes and experiences during office-based opioid treatment (OBOT) in the COVID-19 pandemic. This study specifically aims to evaluate attitudes and experiences of people prescribe buprenorphine across five domains with the hope of evaluating a) whether telemedicine has improved their access to and experiences with OBOT; b) the factors that motivate individuals in OBOT to abstain from opioid drug use; c) how patients' view the use of cannabis, benzodiazepines, and nicotine during OBOT; d) the degree to which patients in OBOT report using cannabis, benzodiazepines, and nicotine and how their use might have changed during the COVID-19 pandemic; and e) whether patients attitudes towards cannabis, benzodiazepines, and cigarettes/e-cigarettes are associated with their use of those same substances.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Survey 1 | – | –Survey investigating patients' experiences with buprenorphine treatment for Opioid Use Disorder before and during the COVID-19 pandemic |
| Survey 2 | – | –Survey investigating the factors that motivate patients to abstain from opioid drug use during buprenorphine treatment for Opioid Use Disorder |
| Survey 3 | – | –Survey investigating patients' attitudes towards and experiences with cannabis use during buprenorphine treatment for Opioid Use Disorder. |
| Survey 4 | – | –Survey investigating patients' attitudes towards and experiences with cigarettes and e-cigarettes use during buprenorphine treatment for Opioid Use Disorder. |
| Survey 5 | – | –Survey investigating patients' attitudes towards and experiences with benzodiazepine use during buprenorphine treatment for Opioid Use Disorder. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population consists of adults aged 18+ who live in Massachusetts and are currently prescribed buprenorphine by a healthcare provider to treat OUD. Those under the age of 18 will be screened out of the investigation during the consent process. In addition, because many of the survey questions used in this investigation are based on established survey instruments that were created in the English language and validated among English-speaking participants, we will limit the subject population or this study to English-speaking adults.
Key inclusion criteria (5 listed)
- Participants must be 18 years of age or older.
- Participants report currently having a legal prescription for buprenorphine for opioid use disorder.
- Participants must have a past or present opioid use disorder.
- Participants must currently reside in the state of Massachusetts.
- Participants must be able to comprehend the English language.
Key exclusion criteria (3 listed)
- Unable to complete an online survey.
- Unable to complete a verification step that ensures bots are not used to complete survey.
- Complete a survey with no variation suggesting they did not read the survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient's Experiences with Office-Based Opioid Treatment
Time frame: Day 1
This is an eight-item scale that measures the degree to which participants report being able to access buprenorphine treatment-related appointments and medications before and during the COVID-19 pandemic. Participants will be asked to rate each of the eight questions on a 7-point Likert scale from 1 = "extremely easy" to 7= "extremely difficult."
Reasons for Abstaining from Opioids Questionnaire
Time frame: Day 1
This 17-item scale will measure participant ratings of the importance of 17 factors that motivate abstinence from illicit drug use during office-based opioid treatment. Participants will be asked to rate each of these 17 items on a scale from 0 = "not at all important" to 4 = "extremely important."
Patients' Attitudes Toward the Use of Cannabis During Office-Based Opioid Treatment
Time frame: Day 1
Participants will rate three items on a scale of 1 = "completely disagree" to 7 = "completely agree." Specifically, participants will rate the degree to which they feel cannabis use is acceptable during office-based opioid treatment (OBOT), they believe that their prescribers' feel cannabis use is acceptable during OBOT, and they feel comfortable discussing cannabis use with their buprenorphine prescribers.
Patients' Attitudes Toward the Use of Cigarettes/E-Cigarettes During Office-Based Opioid Treatment
Time frame: Day 1
Participants will rate three items on a scale of 1 = "completely disagree" to 7 = "completely agree." Specifically, participants will rate the degree to which patients should be encouraged to quit smoking cigarettes and e-cigarette during office-based opioid treatment (OBOT) and the degree to which they feel smoking helps manage cravings during OBOT.
Patients' Attitudes Toward and Experiences with the Use of Benzodiazepines during Office-Based Opioid Treatment
Time frame: Day 1
Participants will rate three items on a scale of 1 = "completely disagree" to 7 = "completely agree." Specifically, participants will rate the degree to which benzodiazepine use is acceptable during office-based opioid treatment (OBOT), they feel OBOT providers find benzodiazepine use by their patients acceptable, and they feel comfortable openly discussing their benzodiazepine use with their buprenorphine prescriber.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
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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.
Zev Schuman-Olivier, MD principal investigator
Cambridge Health Alliance
Joseph Rosansky study director
Cambridge Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder and Acceptability of Health Care, run by Cambridge Health Alliance 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 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 11 Jul 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?
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?
Patient's Experiences with Office-Based Opioid Treatment (time frame: Day 1). The study lists 5 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 11 Jul 2025.