Division
HEAL Study
Title
Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder
Short Description
This pilot study examines the feasibility and acceptability of transitioning office-based buprenorphine treatment of opioid use disorder from physicians to pharmacists. Results from this study will inform the development of a future multi-site randomized clinical trial.
Release Date
Feb 16, 2023
Description

The overall objective of this study is to explore the feasibility of transitioning the care of adult patients with opioid use disorder (OUD) who receive office-based buprenorphine treatment (OBBT) from physicians to pharmacists. Physicians will induce buprenorphine treatment and complete the stabilization phase before referring patients to pharmacists for the management of monthly maintenance visits. This study will assess the feasibility and acceptability of a collaborative care model between physician and pharmacist by measuring recruitment rate, treatment retention rate, treatment compliance rate, and participants' substance use. Other assessments measured will include treatment fidelity, participant, physician, and pharmacist satisfaction with OUD care, participant safety, and the pharmacists' use of electronic health records and the Prescription Drug Monitoring Program.

Accessibility Notice

Please note that the supplementary documents may not be fully Section 508 compliant. Please contact us for assistance.

Study Data
Study Links
Study Documents

Treatment Satisfaction Survey

Submitted by aplank on
Abbreviation
TSS
Description

Satisfaction with treatment delivery by participants will be measured using the Treatment Satisfaction Survey (adapted from Harland et al., 2005) at each visit. The proportion of visits in which participants are satisfied (score of 4 on a Likert Scale of 1-5) or very satisfied (score of 5 on a Likert Scale of 1-5) will be calculated.

Category
Health Cognitions & QOL
Division
HEAL Study
Title
Ph1 Marinol Interaction Study - Part 1
Short Description
Phase 1 Pilot Study To Examine The Cardiovascular Effects Of Smoked Marijuana, Interactions With Oral Dronabinol, And Effects Of Dronabinol On Withdrawal In Marijuana Dependent Volunteers - Part 1
Release Date
Nov 30, 2022
Description

This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant drug interactions before conducting outpatient studies. Part One is a pilot study to characterize the cardiovascular effects/safety, subjective effects, and PK of smoked marijuana and to familiarize study staff with the conduct of controlled smoking sessions.

Accessibility Notice

Please note that the supplementary documents may not be fully Section 508 compliant. Please contact us for assistance.

Study Data
Study Links
Study Documents

Marijuana Withdrawal Symptom Checklist

Submitted by aplank on
Abbreviation
MWSC
Description

The MWSC is a 10-item self-administered questionnaire developed by Budney et al. (1999). Each of the 10 items is a withdrawal symptom that is rated on a 4-point scale as follows: 0 = not at all; 1 = mild; 2 = moderate; 3 = severe. The 10 withdrawal symptoms include: 1) craving, 2) irritability, 3) nervousness, 4) depression, 5) anger, 6) restlessness, 7) sleep problems, 8) decreased appetite, 9) strange dreams, and 10) headaches. Symptoms will be evaluated individually and by computing a total withdrawal discomfort score (WDS) that is the sum of the individual item scores.

Category
Substance Use
Subcategory
Drugs
Division
HEAL Study
Investigator(s)
Title
Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder (ADAPT-2)
Short Description
This is a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder. Participants will be randomly assigned to the active medication combination (AMC) group or matching placebo group and will receive medications over the course of 12 weeks. Follow-ups will occur in weeks 13 and 16.
Release Date
Oct 07, 2022
Description

There will be 400 adults with moderate or severe methamphetamine use disorder randomized into this multi-site study. Eligibility will be determined during a maximum 21 day screening period. After screening is completed and eligibility is confirmed, including successful administration of a naloxone challenge, participants will begin the 12 week medication phase of the trial. Participants will be randomized to either the 1) AMC arm and receive injections of extended release naltrexone (XR-NTX; as Vivitrol®) plus once-daily oral extended-release bupropion tablets (BUP-XL) or the 2) matching placebo (PLB) arm and receive injections of placebo (iPLB) plus once-daily oral placebo (oPLB) tablets. During the course of the study, participants may be switched to another arm, as determined by the a priori adaptive aspect of the study design. Participants appearing to respond well to their original treatment assignment will not be switched. Overall, approximately 50% of the participants will receive the AMC. Injections will be administered every three weeks, in weeks 1, 4, 7, and 10. Take-home oral study medication (BUP-XL or oPLB) will be dispensed weekly for dosing on non-clinic days. Participants will be asked to attend the clinic twice weekly for observed oral medication dosing, assessments, collection of urine samples, and once-weekly medical management. On non-clinic days, participants will participate in smartphone app-based medication adherence activities. Participants will be asked to complete assessments as indicated on the schedule of assessments. Following the 12 week medication phase, participants will complete a follow-up phase, including a medication taper and post-medication phase follow-up visits during weeks 13 and 16.

Accessibility Notice

Please note that the supplementary documents may not be fully Section 508 compliant. Please contact us for assistance.

Study Data
Study Links
Study Documents