Evaluation of Doxazosin to Alter the Abuse of Oxycodone
Status:
Terminated
Trial end date:
2019-12-23
Target enrollment:
Participant gender:
Summary
Healthy, adult men and women, aged 21 to 59 years, who abuse opioids and are physically
dependent on them will be recruited to participate in a study to examine the ability of
doxazosin, an epinephrine receptor blocker, to alter the abuse potential of oxycodone. After
participants complete the screening process, they will be scheduled for inpatient admission
onto our clinical inpatient where they will reside during the 8-week study. During Weeks 1-2,
participants will be transitioned from their normal opioid use regime onto oral morphine
until withdrawal dissipates. At this time participants will also be stabilized on the first
dose of doxazosin (0 or 16 mg/day; active doxazosin will be started at 4 mg and increased by
4 mg every 3 days). During Weeks 3-4, either active or placebo oxycodone will be available
(in random order). Monday-Friday each these drugs will be tested using our sample and choice
self-administration procedure. On Friday, participants will also complete a cue exposure
session during which they will be presented drug cues to determine whether the study
medication affects how participants react to them. To summarize, Weeks 1-2 and 5-6 will be
stabilization weeks (0 or 16 mg doses of doxazosin administered in random order) and Weeks
3-4 and 7-8 will be test weeks under each of the doxazosin maintenance doses. At the
conclusion of the study, participants will be given an exit interview, warnings about
re-initiation of opioid use, and counseling about the different treatment options for Opioid
Use Disorder. Within 1 week after discharge, investigators will assess adverse events using
the a number of clinical assessments. At each weekly visits, investigators will assess
participants' interest in treatment and drug use patterns.