An App to Aid in Transitioning Off Opiate Replacement Therapy



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 65
Updated:7/12/2018
Start Date:April 1, 2016
End Date:June 30, 2019
Contact:Ana Abrantes, PhD
Email:ana_abrantes@brown.edu

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A Smartphone App to Facilitate Buprenorphine Discontinuation

The investigators propose to develop a smartphone app (called OFFBup) that will help patients
manage opioid withdrawal during buprenorphine taper and detoxification. The OFFBup smartphone
intervention will be a resource patients can access anytime and anywhere. If the OFFBup
intervention were to be effective in helping patients undergoing buprenorphine detoxification
by decreasing relapse to illicit drug use, it could be integrated into the standard of care
of office-based buprenorphine clinical practices, as well as methadone programs, thereby
having a substantial public health impact.

In the last decade, the rates of opioid misuse and entry in substance abuse treatment for
opioid dependence have increased significantly. An increasing number of opioid dependent
individuals are being treated with buprenorphine (an effective, safe, more convenient,
accessible alternative to methadone treatment). After a period of maintenance for patients,
the majority of opioid dependent patients are interested in coming off the medication, either
out of personal preference (e.g., don't want to substitute on addiction for another) or
necessity (e.g., can't afford it). Buprenorphine discontinuation, even when planned as a
dosing taper, is often associated with opiate withdrawal and many patients express concern
about the anticipated withdrawal symptoms; in turn, many experience decreased self-efficacy
to remain abstinent during the process. There is a lack of available treatment resources to
help patients manage buprenorphine discontinuation effectively. Therefore, the investigators
propose to harness the advantages afforded by existing technologies to address this
important, unmet treatment need. The investigators propose to develop a smartphone
application (called OFFBup) that will help patients manage withdrawal during buprenorphine
taper and detoxification. The components of the OFFBup application will be consistent with
Relapse Prevention Theory (e.g., coping with withdrawal, increasing self-efficacy) and
operationalized following the tenets of Self-Determination Theory (i.e., competence,
autonomy, and relatedness). After the development of the OFFBup application, we will conduct
a small RCT of 50 opioid dependent patients undergoing buprenorphine discontinuation to
determine the feasibility and preliminary efficacy of the OFFBup application. The OFFBup
smartphone intervention will be a resource where patients can access (anytime and anywhere)
educational information, emotional and instrumental support, and that permits self-monitoring
with accompanying feedback. If the OFFBup application were to be effective in helping
patients undergoing buprenorphine detoxification by decreasing relapse to illicit drug use,
it could be integrated into the standard of care of office-based buprenorphine clinical
practices, as well as methadone programs, thereby having a substantial public health impact.

Inclusion Criteria:

- between 18-65 years of age;

- currently receiving buprenorphine treatment for opioid dependence;

- has begun tapering off of buprenorphine and is at a daily dose of 2-4 mg/d;

- four or less weeks remaining on buprenorphine taper; and

- has a smartphone or is willing to use one supplied by the study.

Exclusion Criteria:

- non-English speaking.
We found this trial at
1
site
345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Principal Investigator: Ana M. Abrantes, Ph.D.
Phone: 401-455-6440
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
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mi
from
Providence, RI
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