Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence
NCT ID: NCT03015246
Last Updated: 2020-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
26 participants
INTERVENTIONAL
2016-12-31
2020-08-31
Brief Summary
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Detailed Description
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Participants will receive a medication called Buprenorphine/Naloxone. Buprenorphine/Naloxone is approved by the Food and Drug Administration (FDA) to treat opioid addiction, and is a safe and effective alternative to methadone. Participants will receive this medication every day. When participants are not living on the inpatient unit they will come to the research clinic every day to receive the medication.
On Day 1, one single 1-mL (0.2 teaspoon) blood sample will be collected to assess the effect of the Buprenorphine/Naloxone medication dose on gene expression pattern.
On each day of admission (once on weeks 3, 5 and 7), a single 1-mL (0.2 teaspoon) blood sample will be collected to assess the effect of the buprenorphine/naloxone medication dose on the participant's gene expression pattern.
On the 8 days while participants are an inpatient they will participate in experimental sessions that involve drug administration. On some days participants will receive morphine and on some days participants will receive oral medications called yohimbine and hydrocortisone that will be used to study stress responses. Each afternoon study staff will collect one blood sample (10 mL or 2 teaspoons) from a vein in the participant's arm; these samples will be used to measure biological signals of stress.
At the end of the study participants will be detoxified from the Buprenorphine/Naloxone medication over a 3-week outpatient period.
Study participants will be scheduled for one separate in-person visit at 1 month after week 11. At this follow-up visit participants will be asked to provide a urine sample and to complete questionnaires that ask about drug craving and use, withdrawal symptoms, risky situations for drug use, coping with stress, and consequences experienced from using drugs or being abstinent.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Extended-Release Morphine + placebo stressor
Participants will be maintained on extended-release morphine (dose tailored to the individual, based on pre-experimental opioid use amount), in three divided daily doses. The placebo stressor will be administered on one day.
Extended release morphine
Dose (tailored to each participant based on his/her pre-experimental opioid use amount) is administered in 3 divided daily doses.
Placebo stressor
Lactose
Buprenorphine/Naloxone low dose + placebo stressor
Participants will be maintained on Buprenorphine/Naloxone (Zubsolv™) sublingual tablet doses of 1.4/0.36 mg/day. The placebo stressor will be administered on one day.
Buprenorphine/Naloxone low dose
Buprenorphine/Naloxone dose of 1.4/0.36 mg/day
Placebo stressor
Lactose
Buprenorphine/Naloxone moderate dose + placebo stressor
Participants will be maintained on Buprenorphine/Naloxone (Zubsolv™) sublingual tablet doses of 4.2/1.08 mg/day. The placebo stressor will be administered on one day.
Buprenorphine/Naloxone moderate dose
Buprenorphine/Naloxone dose of 4.2/1.08 mg/day
Placebo stressor
Lactose
Buprenorphine/Naloxone high dose + placebo stressor
Participants will be maintained on Buprenorphine-Naloxone (Zubsolv™) sublingual tablet doses of 12.8/3.16 mg/day. The placebo stressor will be administered on one day.
Buprenorphine/Naloxone high dose
Buprenorphine/Naloxone dose of 12.8/3.16 mg/day
Placebo stressor
Lactose
Extended-Release Morphine + active stressor
Participants will be maintained on extended-release morphine (dose tailored to the individual, based on pre-experimental opioid use amount), in three divided daily doses. Yohimbine 60mg powder + Hydrocortisone (Cortef™) 20mg tablet administered on one day.
Extended release morphine
Dose (tailored to each participant based on his/her pre-experimental opioid use amount) is administered in 3 divided daily doses.
Active stressor
Yohimbine hydrochloride 60mg + Hydrocortisone 20mg tablet
Buprenorphine/Naloxone low dose + active stressor
Participants will be maintained on Buprenorphine/Naloxone (Zubsolv™) sublingual tablet doses of 1.4/0.36 mg/day. The placebo stressor will be administered on one day. Yohimbine 60mg powder + Hydrocortisone (Cortef™) 20mg tablet administered on one day.
Buprenorphine/Naloxone low dose
Buprenorphine/Naloxone dose of 1.4/0.36 mg/day
Active stressor
Yohimbine hydrochloride 60mg + Hydrocortisone 20mg tablet
Buprenorphine/Naloxone moderate dose + active stressor
Participants will be maintained on Buprenorphine/Naloxone (Zubsolv™) sublingual tablet doses of 4.2/1.08 mg/day. Yohimbine 60mg powder + Hydrocortisone (Cortef™) 20mg tablet administered on one day.
Buprenorphine/Naloxone moderate dose
Buprenorphine/Naloxone dose of 4.2/1.08 mg/day
Active stressor
Yohimbine hydrochloride 60mg + Hydrocortisone 20mg tablet
Buprenorphine/Naloxone high dose + active stressor
Participants will be maintained on Buprenorphine-Naloxone (Zubsolv™) sublingual tablet doses of 12.8/3.16 mg/day. Yohimbine 60mg powder + Hydrocortisone (Cortef™) 20mg tablet administered on one day.
Buprenorphine/Naloxone high dose
Buprenorphine/Naloxone dose of 12.8/3.16 mg/day
Active stressor
Yohimbine hydrochloride 60mg + Hydrocortisone 20mg tablet
Interventions
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Extended release morphine
Dose (tailored to each participant based on his/her pre-experimental opioid use amount) is administered in 3 divided daily doses.
Buprenorphine/Naloxone low dose
Buprenorphine/Naloxone dose of 1.4/0.36 mg/day
Buprenorphine/Naloxone moderate dose
Buprenorphine/Naloxone dose of 4.2/1.08 mg/day
Buprenorphine/Naloxone high dose
Buprenorphine/Naloxone dose of 12.8/3.16 mg/day
Active stressor
Yohimbine hydrochloride 60mg + Hydrocortisone 20mg tablet
Placebo stressor
Lactose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive urine test for opiates
* Willing to use an adequate form of contraception for the duration of the study.
* Reads and writes English
* Participants must be in generally good health to be eligible. All candidates will receive a routine medical exam (history and physical) with standard laboratory tests (including blood and urine samples, EKG, mandatory TB testing, and voluntary HIV testing).
Exclusion Criteria
* Candidates meeting criteria for opioid or nicotine dependence will not be excluded, but those with other Substance Dependence disorders will be excluded. Those with Abuse of Alcohol, Cannabis, Cocaine, will not be excluded, but participants must provide an alcohol free breath specimen.
* No candidate with medical (neurological, cardiovascular, pulmonary or systemic) disorders will be allowed to participate. This will be determined with history and physical exam, standard laboratory testing (blood and urine), EKG, and TB tests (to avoid transmitting this communicable disease on the residential unit or in the laboratory).
* Candidates with evidence of cognitive impairment (based on reading ability and comprehension, will be excluded.
* Female candidates who are pregnant (urine pregnancy test), lactating, or not using adequate birth control methods (self-report) will be excluded.
* Candidates with injection phobia, or seeking treatment for opioid dependence will be excluded.
18 Years
55 Years
ALL
No
Sponsors
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Wayne State University
OTHER
Responsible Party
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Mark Greenwald, PhD
Professor of Psychiatry and Behavioral Neurosciences; and Director, Substance Abuse Research Division
Principal Investigators
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Mark Greenwald, PhD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
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Vince and Associates
Overland Park, Kansas, United States
Countries
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Other Identifiers
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BOS-1
Identifier Type: -
Identifier Source: org_study_id