Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence
BOS
Biobehavioral Studies of Opioid Seeking: Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence
1 other identifier
interventional
26
1 country
1
Brief Summary
This research deals with behaviors that are part of opioid dependence. The purpose is to study how stress and medication dose can affect opioid drug use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 16, 2016
CompletedFirst Posted
Study publicly available on registry
January 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedNovember 10, 2020
November 1, 2020
3.5 years
December 16, 2016
November 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Opioid price-inelasticity (economic demand)
demand intensity (L) and demand elasticity (a) on hypothetical drug purchasing task
measured once (end of session) in each of the 8 experimental sessions over 7 weeks
Secondary Outcomes (12)
Opioid Symptom Questionnaire: Agonist symptoms
Within-session change is being assessed, in each of 8 sessions over 7 weeks. Within-session measurements at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600.
Opioid Symptom Questionnaire: Withdrawal symptoms
Within-session change is being assessed, in each of 8 sessions over 7 weeks. Within-session measurements at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600.
Visual Analog Scale (VAS) ratings
Within-session change is being assessed, in each of 8 sessions over 7 weeks. Within-session measurements at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600.
Profile of Mood States (POMS)
Within-session change is being assessed, in each of 8 sessions over 7 weeks. Within-session measurements at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600.
Blood pressure
Within-session change is being assessed, in each of 8 sessions over 7 weeks. Within-session measurements at baseline 0930, 1030, 1145, 1230, 1300, 1330, 1400, 1430, 1500, and 1600.
- +7 more secondary outcomes
Study Arms (8)
Extended-Release Morphine + placebo stressor
PLACEBO COMPARATORParticipants 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.
Buprenorphine/Naloxone low dose + placebo stressor
EXPERIMENTALParticipants 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 moderate dose + placebo stressor
EXPERIMENTALParticipants 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 high dose + placebo stressor
EXPERIMENTALParticipants 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.
Extended-Release Morphine + active stressor
EXPERIMENTALParticipants 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.
Buprenorphine/Naloxone low dose + active stressor
EXPERIMENTALParticipants 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 moderate dose + active stressor
EXPERIMENTALParticipants 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 high dose + active stressor
EXPERIMENTALParticipants 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.
Interventions
Dose (tailored to each participant based on his/her pre-experimental opioid use amount) is administered in 3 divided daily doses.
Buprenorphine/Naloxone dose of 1.4/0.36 mg/day
Buprenorphine/Naloxone dose of 4.2/1.08 mg/day
Buprenorphine/Naloxone dose of 12.8/3.16 mg/day
Yohimbine hydrochloride 60mg + Hydrocortisone 20mg tablet
Lactose
Eligibility Criteria
You may qualify if:
- Opioid dependent, as determined by structured clinical interview for DSM-IV (SCID) and Addiction Severity Index (ASI)
- 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).
You may not qualify if:
- No candidate who has a current DSM-IV Axis I disorder other than Drug Dependence or a history of serious psychiatric problems (e.g. psychosis, bipolar or major depression) will be allowed to participate.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vince and Associates
Overland Park, Kansas, 66212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Greenwald, PhD
Wayne State University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Medication conditions blinded using different-sized buprenorphine/naloxone sublingual tablets including placebo. Stress conditions blinded using encapsulation of yohimbine/placebo and hydrocortisone/placebo. Only pharmacy aware of drug codes.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychiatry and Behavioral Neurosciences; and Director, Substance Abuse Research Division
Study Record Dates
First Submitted
December 16, 2016
First Posted
January 10, 2017
Study Start
December 1, 2016
Primary Completion
June 1, 2020
Study Completion
August 1, 2020
Last Updated
November 10, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share