A Phase 1/2 interventional study of Extended release morphine and Buprenorphine/Naloxone low dose in Heroin Dependence and Opioid Use Disorder, sponsored by Wayne State University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-11-10.
Sponsored by Wayne State University · Phase 1/2, Interventional, and Basic science
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.
If participants meet all the criteria, their involvement in the study (Phases 1 and 2 described below) will last for 10-13 weeks. Participants will be asked to stay at the research site for a minimum of 2 nights on 4 separate weeks and will have 22 office visits During that time, participants can't leave the unit unescorted or have visitors.
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.
Exclusion Criteria:
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.
Drug: Extended release morphine · Drug: 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.
Drug: Buprenorphine/Naloxone low dose · Drug: 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.
Drug: Buprenorphine/Naloxone moderate dose · Drug: 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.
Drug: Buprenorphine/Naloxone high dose · Drug: 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. Yohimbine 60mg powder + Hydrocortisone (Cortef™) 20mg tablet administered on one day.
Drug: Extended release morphine · Drug: 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.
Drug: Buprenorphine/Naloxone low dose · Drug: 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.
Drug: Buprenorphine/Naloxone moderate dose · Drug: 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.
Drug: Buprenorphine/Naloxone high dose · Drug: Active stressor
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
Also known as: Zubsolv™ sublingual tablet
Buprenorphine/Naloxone dose of 4.2/1.08 mg/day
Also known as: Zubsolv™ sublingual tablet
Buprenorphine/Naloxone dose of 12.8/3.16 mg/day
Also known as: Zubsolv™ sublingual tablet
Yohimbine hydrochloride 60mg + Hydrocortisone 20mg tablet
Lactose
Opioid price-inelasticity (economic demand)
demand intensity (L) and demand elasticity (a) on hypothetical drug purchasing task
Time frame: measured once (end of session) in each of the 8 experimental sessions over 7 weeks
Opioid Symptom Questionnaire: Agonist symptoms
Total opioid agonist symptom score (16 items, each scored on 0-4 scale, for a scale score range of 0-64, with higher scores indicating higher opioid agonist symptoms)
Time frame: 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
Total opioid withdrawal symptom score (16 items, each scored on 0-4 scale, for a scale score range of 0-64, with higher scores indicating higher withdrawal symptoms)
Time frame: 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
VAS ratings will measure "liking", "good drug effect," "bad drug effect," "stimulated," "sedated", "\[preferred opioid\] craving", and "cigarette craving". Each VAS is scored from 0 (not at all) to 100 (extremely).
Time frame: 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)
72-item POMS questionnaire, which has several subscale scores
Time frame: 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
Systolic/diastolic blood pressure (mm Hg)
Time frame: 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.
Heart rate
Heart rate (beats/min)
Time frame: 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.
Pupil diameter
Pupil diameter (mm) measured with digital pupillometer
Time frame: 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.
Plasma noradrenaline level
Plasma noradrenaline level (µg/ml)
Time frame: Measured once per session at 2-hours post Yohimbine in each of the 8 experimental sessions
Plasma BDNF level (µg/ml)
Plasma brain derived neurotrophic factor level (pg/ml)
Time frame: Measured once per session at 2-hours post Yohimbine in each of the 8 experimental sessions
Plasma IL-1Ra level (µg/ml)
Plasma interleukin 1Ra level (pg/ml)
Time frame: Measured once per session at 2-hours post Yohimbine in each of the 8 experimental sessions
Saliva cortisol level
Saliva cortisol level (µg/dL)
Time frame: Within-session change is being assessed, in each of 8 sessions over 7 weeks. Within-session measurements at baseline, 1.5, 2, 3 and 4 hours post Yohimbine in each of the 8 experimental sessions.
Saliva alpha-amylase level
Saliva alpha-amylase level (U/dL)
Time frame: Within-session change is being assessed, in each of 8 sessions over 7 weeks. Within-session measurements at baseline, 1.5, 2, 3 and 4 hours post Yohimbine in each of the 8 experimental sessions.
Plan to share: No
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Wayne State University