NCT05121428

Brief 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.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
817

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Nov 2021Mar 2027

First Submitted

Initial submission to the registry

October 21, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 16, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

November 20, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2027

Expected
Last Updated

July 11, 2025

Status Verified

June 1, 2025

Enrollment Period

3.3 years

First QC Date

October 21, 2021

Last Update Submit

July 8, 2025

Conditions

Keywords

Opioid Use DisorderSubstance Use DisordersBuprenorphineSuboxoneCannabisCigarettesE-CigarettesBenzodiazepinesHealthcareCOVID-19TelemedicineOffice-Based Opioid TreatmentFacebookSocial MediaNicotineRecovery

Outcome Measures

Primary Outcomes (5)

  • 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."

    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."

    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.

    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.

    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.

    Day 1

Study Arms (5)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Center for Mindfulness and Compassion

Cambridge, Massachusetts, 02141, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersPatient Acceptance of Health CareSubstance-Related DisordersMarijuana AbuseVapingCOVID-19

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehaviorSmokingPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Zev Schuman-Olivier, MD

    Cambridge Health Alliance

    PRINCIPAL INVESTIGATOR
  • Joseph Rosansky

    Cambridge Health Alliance

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 16, 2021

Study Start

November 20, 2021

Primary Completion

March 20, 2025

Study Completion (Estimated)

March 20, 2027

Last Updated

July 11, 2025

Record last verified: 2025-06

Locations