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Opioid-use DisorderPhase 2NCT03415581

Evaluation of Doxazosin to Alter the Abuse of Oxycodone

A Phase 2 study testing Intranasal Oxycodone and Cue Session in people with Opioid-use Disorder, run by New York State Psychiatric Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 59 years
Conditions the study is for
Opioid-use Disorder
What is being tested?
Intranasal Oxycodone and Cue Session
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
1 siteUnited States
Study dates
12 Feb 2017to 23 Dec 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 59 years
  • All sexes
  • No healthy volunteers
  • Adult

Participants must meet all of the following inclusion criteria to be enrolled into the study:

  1. 21-59 years of age. Ascertained by: Self-reported age and/or verification with legal identification.
  2. Diagnostic criteria for Opioid Use Disorder moderate-severe (304.00) as per DSM-V Ascertained by: Clinical interviews (telephone, psychologist, nurse, physician), naloxone challenge test/visual evidence of opioid withdrawal.
  3. No current or past diagnosis of schizophrenia, schizoaffective disorder, or other psychotic disorder; bipolar I or bipolar II disorder, other major mood, psychotic, or anxiety disorder that might interfere with the study. Ascertained by: Clinical interview with physician or nurse.
  4. Physically healthy. Ascertained by: Clinical interview with physician, laboratory tests (urinalysis, blood chemistry, 12-lead ECG), physical examination, self-reported medical history.
  5. Able to perform study procedures. Ascertained by: Practice session or Clinical Judgement (Psychologist or Physician)
  6. Normal body weight. Ascertained by: Body Mass Index <30.
  7. Current or history of intranasal opioid use. Ascertained by: Clinical interviews (telephone, psychologist, and psychiatric NP, or physician).
  8. Current intranasal or intravenous use of opioids in amounts and/or frequencies that meet or exceed those used in the proposed study (e.g., 3-4 tablets of a prescription opioid medication per day or 1-2 bags of heroin per day). Ascertained by: Clinical interviews (telephone, psychologist, psychiatric NP, or physician)
  9. If female and using oral contraceptives, must use alternative forms of contraception as well (e.g. condoms in combination with spermicide). Ascertained by: Clinical interviews (telephone, psychologist, nurse, physician), physical examination.
  10. Has not participated in another opioid laboratory study within the past 3 months. Ascertained by: Clinical interviews (psychologist physician, or psychiatric NP), review of laboratory records.

Participants will be excluded from study participation if they meet any of the following exclusion criteria:

  1. Meeting DSM-V criteria for substance use disorder (moderate-severe) on drugs other than opioids, nicotine or caffeine (must be less than 500 mg caffeine daily). Ascertained by: Clinical interview with physician or psychiatric NP, urine screen, observation.
  2. Participants requesting treatment. Ascertained by: Self-report during interview.
  3. Treatment with any investigational drug during the last 30 days. Ascertained by: Self-report during interview.
  4. Participants on parole or probation. Ascertained by: Self-report during interview, criminal background check upon admission.
  5. Currently pregnant or trying to conceive, or currently lactating. Ascertained by: Blood pregnancy testing at screening, on admission and (beta hCG), and self-report during interview and study visits.
  6. Current or recent history of significant violent or suicidal behavior and/or suicidal/homicidal risk. Ascertained by: Clinical interview with a psychiatrist or psychiatric NP, and C-SSRS, MINI, and Beck Depression Inventory (based on current state and history).
  7. Cannot read or understand the self-report assessment forms unaided, or are so severely disabled that they cannot comply with the requirements of the study. Ascertained by: Clinical interview (psychologist, physician, or psychiatric NP), or practice session.
  8. Elevated liver function tests (i.e., AST and ALT > 3 times the upper limit of normal (ULN); bilirubin > 2x ULN; hepatitis B or chronic hepatitis C). Ascertained by: Laboratory tests.
  9. Physical disorders that might make participation hazardous such as AIDS, cancer, baseline hypotension, orthostatic hypotension or syncope, hypertension (blood pressure > 140/90), uncontrolled diabetes, pulmonary hypertension or heart disease (please note that participants will be asked about previous visits to a cardiologist, chest pain, or strong palpitations; if these exist, they will be referred to a cardiologist and excluded unless cleared for participation by a cardiologist). Ascertained by: Clinical interview (psychologist, physician, or psychiatric NP) physical examination, 12-lead ECG.
  10. Current major Axis I psychopathology other than opioid use disorder (e.g., mood disorder with functional impairment or suicide risk, schizophrenia), that might interfere with ability to participate in the study. Ascertained by: Clinical interviews (psychologist, physician, or psychiatric NP).
  11. Sensitivity, allergy, or contraindication to opioids, doxazosin, adrenergic antagonists or agonists, or similar compounds. Ascertained by: Clinical interview (psychologist, physician, or psychiatric NP).
  12. Planning to conceive within 6 months of study participation. Ascertained by: Clinical interview (psychologist, physician, or psychiatric NP).
  13. Use of any prescription, over-the-counter medication that affects CYP3A4 activity are prohibited for at least 7 days prior to the anticipated study start date; or the use of phosphodiesterase inhibitors and MAOIs 14 days prior to the study. Ascertained by: Medical History, Clinical Interview ((psychologist, physician, or psychiatric NP).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jermaine Jones

    Manhattan, New York, 10032

Other trials in United States

About this study

Official title: Doxazosin: Evaluation of Its Ability to Alter the Abuse Liability of Oxycodone in Humans

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.

Read the detailed description

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 alpha-1 adrenergic receptor antagonist, to alter the abuse liability of oxycodone. After participants complete the screening process, they will be scheduled for admission onto the General Clinical Research Unit on 5-South where they will reside during an 8-week study . During Weeks 1-2, participants will be stabilized on morphine and 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; dosing will occur at 8pm each evening). During the stabilization periods, participants will be treated for emergent withdrawal symptoms with supplemental medications until withdrawal symptoms have dissipated.

During Weeks 3-4, either active or placebo oxycodone will be available (order of testing active or placebo oxycodone will be randomized). During active oxycodone weeks, participants will receive a sample dose of intransasal (IN) oxycodone (0, 12.5, 25, 50, or 100 mg/70kg) during morning sessions on Monday-Friday. The sampled reinforcer will be available during afternoon choice sessions using a modified progressive ratio self-administration procedure. During placebo oxycodone weeks, participants will receive a sample dose of placebo oxycodone (0 mg/70kg) during morning sessions on Monday-Thursday followed by afternoon choice sessions. On Friday, participants will receive 25 mg IN oxycodone during a sample session (the oxycodone dose on Fri morning will always be active). When self-administering oxycodone, participants will be instructed to insufflate the entire dose through one or both nostrils within 5-10 seconds. Following the sample session on Fri, participants will complete a cue exposure session during which they will be presented with neutral cues followed by drug cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues after a period of no oxycodone availability. After the cue exposure session on Fri, participants will be given the opportunity to self-administer oxycodone. 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 during which the study will be described. Those who are interested in treatment for their drug use at the end of the study will be offered referrals to studies at our Substance Treatment and Research Service or other treatment providers. Within 1 week after discharge, investigators will assess adverse events, pregnancy (using a urine pregnancy test), general health (complete blood count, blood chemistry, urinalysis, blood pressure, heart rate, body weight, EKG), and suicide (Columbia Suicide Severity Rating Scale).

Being tested
Intranasal Oxycodone, Cue Session
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intranasal OxycodoneDrug

    Also called Oxycodone HCl

    Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.

  • Cue SessionBehavioural

    During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues.

Study groups in NCT03415581
Study groupRoleWhat they receive
Doxazosin (Placebo First)Placebo comparatorMaintenance on a daily dose of oral doxazosin (0 mg) for 4 weeks, followed by 4-week maintenance on active doxasozin (up to 16mg/day or the highest tolerated dose. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.
Receives: Drug: Intranasal Oxycodone; Behavioral: Cue Session
Doxazosin (Active First)Active comparatorMaintenance on a daily dose of oral doxazosin (16 mg, or the highest tolerated dose) for 4-weeks, followed by 4-week maintenance on placebo doxasozin. During this time subjects complete testing sessions (Self-administration, Cue session) assessing the abuse potential of intranasal oxycodone.
Receives: Drug: Intranasal Oxycodone; Behavioral: Cue Session

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid Self-administration

    Clinical laboratory task where the participant is asked to choose between drug and money. Shown as the mean percent of drug choices.

    Measured: Averaged across the 8-week trial.

Secondary outcomes (1)
  1. Opioid Craving

    Self-reported craving for opioid drugs. Participants are asked to indicate the extent to which they agree with the phrase "I want opioids" on a scale of 0 (Not-at-All) to 100 (Completely).

    Measured: Averaged across the 8-week trial.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2018
  2. Study start12 Feb 2017
  3. Primary completion23 Dec 2019
  4. Study completion23 Dec 2019

Why it stopped: Study terminated by sponsor due to bad risk/benefit ratio.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03415581
Sponsor's protocol ID
7547
Status last verified
Mar 2021
First submitted
11 Jan 2018
Last updated
12 Apr 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intranasal Oxycodone and Cue Session in people with Opioid-use Disorder, run by New York State Psychiatric Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Self-administration (time frame: Averaged across the 8-week trial.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.

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