Sponsor study identifier
interventional
26
1 country
1
Study Start
December 2016
Actual (reported)Primary Completion
June 2020
Actual (reported)Study Completion
August 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2016
Actual (reported)December 16, 2016
Actual (reported)January 10, 2017
Actual (reported)June 2020
Actual (reported)August 2020
Actual (reported)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
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.
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.
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.
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
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Buprenorphine/Naloxone low dose
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Buprenorphine/Naloxone moderate dose
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Buprenorphine/Naloxone high dose
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordVince and Associates
Overland Park, Kansas, 66212, United States
Mark Greenwald, PhD
Wayne State University
26 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2016
An Open-Label Pilot Study of Sublocade as Treatment for Opiate Use Disorder
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.
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.
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.
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.
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.
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 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
Contact the study team to confirm eligibility.
First Posted
January 10, 2017
Study Start
December 2016
Actual (reported)Primary Completion
June 2020
Actual (reported)Study Completion
August 2020
Actual (reported)Last Updated
November 10, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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