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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05121428
Other study ID # CHA-IRB-1179/03/21
Secondary ID 3R33AT010125R01C
Status Recruiting
Phase
First received
Last updated
Start date November 20, 2021
Est. completion date March 20, 2025

Study information

Verified date April 2024
Source Cambridge Health Alliance
Contact Joseph Rosansky
Phone 617-575-5802
Email jrosansky@cha.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date March 20, 2025
Est. primary completion date March 20, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Locations

Country Name City State
United States CHA Center for Mindfulness and Compassion Cambridge Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Cambridge Health Alliance National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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