Heroin DependencePhase 1/2BOSNCT03015246
Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence
A Phase 1/2 study testing Extended release morphine, Buprenorphine/Naloxone low dose and Buprenorphine/Naloxone moderate dose in people with Heroin Dependence and Opioid Use Disorder, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Heroin Dependence, Opioid Use Disorder
- What is being tested?
- Extended release morphine, Buprenorphine/Naloxone low dose and Buprenorphine/Naloxone moderate dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Aug 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biobehavioral Studies of Opioid Seeking: Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence
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.
Read the detailed description
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.
- Conditions
- Heroin Dependence, Opioid Use Disorder
- Being tested
- Extended release morphine, Buprenorphine/Naloxone low dose, Buprenorphine/Naloxone moderate dose, Buprenorphine/Naloxone high dose, Active stressor
- Medical subject headings
- Heroin Dependence, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended release morphineDrug
Dose (tailored to each participant based on his/her pre-experimental opioid use amount) is administered in 3 divided daily doses.
Buprenorphine/Naloxone low doseDrug
Also called Zubsolv™ sublingual tablet
Buprenorphine/Naloxone dose of 1.4/0.36 mg/day
Buprenorphine/Naloxone moderate doseDrug
Also called Zubsolv™ sublingual tablet
Buprenorphine/Naloxone dose of 4.2/1.08 mg/day
Buprenorphine/Naloxone high doseDrug
Also called Zubsolv™ sublingual tablet
Buprenorphine/Naloxone dose of 12.8/3.16 mg/day
Active stressorDrug
Yohimbine hydrochloride 60mg + Hydrocortisone 20mg tablet
Placebo stressorDrug
Lactose
| Study group | Role | What they receive |
|---|---|---|
| Extended-Release Morphine + placebo stressor | Placebo comparator | 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. Receives: Drug: Extended release morphine; Drug: Placebo stressor |
| Buprenorphine/Naloxone low dose + placebo stressor | Experimental | 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. Receives: Drug: Buprenorphine/Naloxone low dose; Drug: Placebo stressor |
| Buprenorphine/Naloxone moderate dose + placebo stressor | Experimental | 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. Receives: Drug: Buprenorphine/Naloxone moderate dose; Drug: Placebo stressor |
| Buprenorphine/Naloxone high dose + placebo stressor | Experimental | 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. Receives: Drug: Buprenorphine/Naloxone high dose; Drug: Placebo stressor |
| Extended-Release Morphine + active stressor | Experimental | 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. Receives: Drug: Extended release morphine; Drug: Active stressor |
| Buprenorphine/Naloxone low dose + active stressor | Experimental | 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. Receives: Drug: Buprenorphine/Naloxone low dose; Drug: Active stressor |
| Buprenorphine/Naloxone moderate dose + active stressor | Experimental | 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. Receives: Drug: Buprenorphine/Naloxone moderate dose; Drug: Active stressor |
| Buprenorphine/Naloxone high dose + active stressor | Experimental | 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. Receives: Drug: Buprenorphine/Naloxone high dose; Drug: Active stressor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid price-inelasticity (economic demand)
demand intensity (L) and demand elasticity (a) on hypothetical drug purchasing task
Measured: measured once (end of session) in each of the 8 experimental sessions over 7 weeks
Secondary outcomes (12)
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)
Measured: 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)
Measured: 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).
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Measured once per session at 2-hours post Yohimbine in each of the 8 experimental sessions
Saliva cortisol level
Saliva cortisol level (µg/dL)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionJun 2020
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4x2 within-subject crossover design: 4 medication conditions (morphine first, then 3 doses of buprenorphine/naloxone), crossed with 2 stress conditions (placebo vs. stress \[yohimbine + hydrocortisone\], nested within medication conditions)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Greenwald, PhD, Wayne State University
- Investigators
- Mark Greenwald, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03015246
- Sponsor's protocol ID
- BOS-1
- Acronym
- BOS
- Status last verified
- Nov 2020
- First submitted
- 16 Dec 2016
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral Studies of Opioid Seeking: Effects of Buprenorphine/Naloxone Dose on Experimental Stress Reactivity and Opioid Abstinence
- ClinicalTrials.gov ID
- NCT03015246
- Acronym / sponsor ID
- BOS / BOS-1
- Conditions
- Heroin Dependence, Opioid Use Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
- Model description
- 4x2 within-subject crossover design: 4 medication conditions (morphine first, then 3 doses of buprenorphine/naloxone), crossed with 2 stress conditions (placebo vs. stress [yohimbine + hydrocortisone], nested within medication conditions)
| Arm | Type | Receives |
|---|---|---|
| Extended-Release Morphine + placebo stressor | Placebo comparator | Drug: Extended release morphine, Drug: Placebo stressorParticipants 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 | Experimental | Drug: Buprenorphine/Naloxone low dose, Drug: Placebo stressorParticipants 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 | Experimental | Drug: Buprenorphine/Naloxone moderate dose, Drug: Placebo stressorParticipants 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 | Experimental | Drug: Buprenorphine/Naloxone high dose, Drug: Placebo stressorParticipants 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 | Experimental | Drug: Extended release morphine, Drug: Active stressorParticipants 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 | Experimental | Drug: Buprenorphine/Naloxone low dose, Drug: Active stressorParticipants 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 | Experimental | Drug: Buprenorphine/Naloxone moderate dose, Drug: Active stressorParticipants 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 | Experimental | Drug: Buprenorphine/Naloxone high dose, Drug: Active stressorParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extended release morphineDose (tailored to each participant based on his/her pre-experimental opioid use amount) is administered in 3 divided daily doses. | Drug | Extended-Release Morphine + active stressor, Extended-Release Morphine + placebo stressor |
| Buprenorphine/Naloxone low doseAlso: Zubsolv™ sublingual tabletBuprenorphine/Naloxone dose of 1.4/0.36 mg/day | Drug | Buprenorphine/Naloxone low dose + active stressor, Buprenorphine/Naloxone low dose + placebo stressor |
| Buprenorphine/Naloxone moderate doseAlso: Zubsolv™ sublingual tabletBuprenorphine/Naloxone dose of 4.2/1.08 mg/day | Drug | Buprenorphine/Naloxone moderate dose + active stressor, Buprenorphine/Naloxone moderate dose + placebo stressor |
| Buprenorphine/Naloxone high doseAlso: Zubsolv™ sublingual tabletBuprenorphine/Naloxone dose of 12.8/3.16 mg/day | Drug | Buprenorphine/Naloxone high dose + active stressor, Buprenorphine/Naloxone high dose + placebo stressor |
| Active stressorYohimbine hydrochloride 60mg + Hydrocortisone 20mg tablet | Drug | Buprenorphine/Naloxone high dose + active stressor, Buprenorphine/Naloxone low dose + active stressor, Buprenorphine/Naloxone moderate dose + active stressor, Extended-Release Morphine + active stressor |
| Placebo stressorLactose | Drug | Buprenorphine/Naloxone high dose + placebo stressor, Buprenorphine/Naloxone low dose + placebo stressor, Buprenorphine/Naloxone moderate dose + placebo stressor, Extended-Release Morphine + placebo stressor |
Primary outcome
Opioid price-inelasticity (economic demand)
Time frame: measured once (end of session) in each of the 8 experimental sessions over 7 weeks
demand intensity (L) and demand elasticity (a) on hypothetical drug purchasing task
12 secondary outcomes
Opioid Symptom Questionnaire: 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
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
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)
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
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
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
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
Time frame: Measured once per session at 2-hours post Yohimbine in each of the 8 experimental sessions
Plasma BDNF level (µg/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)
Time frame: Measured once per session at 2-hours post Yohimbine in each of the 8 experimental sessions
Saliva cortisol level
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Greenwald, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Extended release morphine, Buprenorphine/Naloxone low dose and Buprenorphine/Naloxone moderate dose in people with Heroin Dependence and Opioid Use Disorder, run by Wayne State University 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?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 10 Nov 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 price-inelasticity (economic demand) (time frame: measured once (end of session) in each of the 8 experimental sessions over 7 weeks). 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 10 Nov 2020.