Opioid AbusePhase 2MAPNCT05006079
Opioid/Benzodiazepine Polydrug Abuse: Aim 3
A Phase 2 study testing Morphine and Alprazolam in people with Opioid Abuse and Benzodiazepine Abuse, run by Wayne State University at 1 site in United States.
Trial summary
In this study, the investigators will measure affective, neurocognitive and behavioral outcomes related to chronic use of opioids and benzodiazepines (screening phase), and in response to the administration of the opioid morphine, the benzodiazepine alprazolam, morphine then alprazolam, alprazolam then morphine… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Abuse, Benzodiazepine Abuse, Polysubstance Abuse
- What is being tested?
- Morphine and Alprazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2024to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must self-report past 10-year experience taking opioid and sedative drugs (for therapeutic or non-therapeutic reasons), but not necessarily at the same time. As an alternative to the sedative drug exposure requirement, participants must have used alcohol on at least 3 separate days during the past month. Participants may have current mild- or moderate-severity Opioid Use Disorder or current mild- or moderate-severity Sedative Use Disorder;
- must not be seeking treatment for their substance use problems;
- must be in current good overall health
Who cannot join
- meet DSM-5 criteria for current psychosis, bipolar disorder, or severe depression (i.e. severe psychiatric disorder);
- meet DSM-5 criteria for severe substance use disorder for any substance (e.g. Sedative, Opioid, Alcohol);
- past-month benzodiazepine or opioid prescription (which would suggest daily use, tolerance, or withdrawal upon cessation);
- report of past-year any-drug overdose or suicide attempt/ideation;
- exhibit cognitive impairment (IQ < 80 on the Shipley Institute of Living Scale);
- neurological, cardiovascular, pulmonary, or systemic diseases (see specific exclusionary conditions under Protection of Human Subjects);
Show all 13Show fewer
- body mass index > 38 kg/m2;
- females who are pregnant (urine), lactating or heterosexually active (self-report) and not using medically approved birth control;
- treatment with methadone, buprenorphine or naltrexone;
- past 30-day use of contraindicated medications;
- alcohol-positive breath sample (>.02% breath alcohol concentration);
- urine sample positive for methadone, cocaine, amphetamines, or barbiturates (<300 ng/ml)
- intolerance of lactose
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Tolan Park Medical Building
Detroit, Michigan, 48201
Mark Greenwald, PhD, 313-993-3965, mgreen@med.wayne.edu
About this study
Official title: Opioid/Benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies - Study 3
In this study, the investigators will measure affective, neurocognitive and behavioral outcomes related to chronic use of opioids and benzodiazepines (screening phase), and in response to the administration of the opioid morphine, the benzodiazepine alprazolam, morphine then alprazolam, alprazolam then morphine, morphine+alprazolam simultaneously, and placebo (laboratory pharmacology experiment). The latter will enable the investigators to assess the effects of an opioid alone, benzodiazepine alone, concurrent and simultaneous administration of opioid+benzodiazepine, relative to a placebo control.
Read the detailed description
The investigators propose that benzodiazepine/opioid polysubstance abuse is perpetuated by a dual-deficit in affective/hedonic regulation (difficulties modulating emotional reactions relative to the context and the person's long-term goals). Furthermore, the investigators propose that this dual-deficit biases neurocognition (interferes with executive function) and behaviors (guided by negative reinforcement processes such that polysubstance use acutely blunts aversive states and directs actions away from natural rewards). The scientific premise for this project builds on George Koob's foundational concept that addiction is a 'reward-deficit/stress-surfeit disorder'. There is an urgent need to obtain clinical pharmacology and mechanistic data to test this hypothesis of dual-deficit in affective/hedonic regulation. This study will use human laboratory methods to test affective, neurocognitive and behavioral mechanisms that maintain benzodiazepine/opioid polysubstance abuse.
The screening phase of this human laboratory study will include measures of affective dysregulation related to benzodiazepine/opioid polysubstance use behaviors. These include distress tolerance, pain sensitivity and nocebo responding, and biomarkers (e.g. plasma cortisol). Also, the investigators will include behavioral measures of drug and non-drug reinforcement (e.g. economic simulations of price elasticity of alprazolam and morphine) and neurocognition (e.g. drug attentional bias, response inhibition, cognitive flexibility).
During the pharmacology study the investigators will administer oral placebo, morphine alone and alprazolam doses alone, as well as morphine and alprazolam sequentially (in counterbalanced order) and simultaneously. Following each drug administration, the investigators will measure responses in affective (e.g. anxiety levels, distress tolerance), neurocognitive (e.g. executive function, learning) and behavioral domains (e.g. impulsivity, psychomotor function, reinforcer preferences). The lab study is highly significant because we lack prospective, controlled, dose-response studies that identify whether opioids, benzodiazepines, and their combination modulate core phenotypes that underlie this harmful polysubstance abuse. Testing effects of both sequential and simultaneous benzodiazepine/opioid administration within the same individuals will establish a firm foundation for understanding which phenotypes are sensitive to disruption and may respond to treatment.
Findings from this study will help to focus clinical assessment and identify mechanisms that maintain benzodiazepine/opioid polysubstance abuse, toward the development of novel medication-assisted, evidence-based psychosocial interventions.
- Conditions
- Opioid Abuse, Benzodiazepine Abuse, Polysubstance Abuse
- Being tested
- Morphine, Alprazolam, Placebo
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
immediate release oral 15mg dose
AlprazolamDrug
oral 0.25mg dose
PlaceboDrug
Lactose
| Study group | Role | What they receive |
|---|---|---|
| Placebo drug | Placebo comparator | Lactose, administered both at 9:30 am and 12:00 pm Receives: Drug: Placebo |
| Morphine alone | Active comparator | 15mg immediate-release oral morphine, administered both at 9:30 am and 12:00 pm Receives: Drug: Morphine |
| Alprazolam alone | Active comparator | 0.25mg oral alprazolam, administered at both 9:30 am and 12:00 pm Receives: Drug: Alprazolam |
| Morphine then alprazolam | Active comparator | 15mg oral morphine administered at 9:30 am, then 0.25mg oral alprazolam administered at 12:00 pm Receives: Drug: Morphine; Drug: Alprazolam |
| Alprazolam then morphine | Active comparator | 0.25mg oral alprazolam administered at 9:30 am, then 15mg oral morphine administered at 12:00 pm Receives: Drug: Morphine; Drug: Alprazolam |
| Morphine+alprazolam simultaneously | Active comparator | morphine 15mg + 0.25mg alprazolam at 9:30 am, then morphine 15mg + 0.25mg alprazolam at 12:00 pm Receives: Drug: Morphine; Drug: Alprazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
State anxiety
State Trait Anxiety Inventory - state anxiety scale total score
Measured: within-session peak change from pre-drug baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Positive affect
Positive and Negative Affect Scale-Short Form (PANAS-SF) positive affect scale score
Measured: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Negative affect
Positive and Negative Affect Scale-Short Form (PANAS-SF) negative affect scale score
Measured: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Secondary outcomes (16)
Symbol matching performance task
Digit Symbol Substitution Task (DSST) symbol matching total score
Measured: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Impulsivity performance task accuracy
Go/No task percentage of trials correct
Measured: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Cognitive flexibility performance task
Wisconsin Card Sorting Task (WCST) percentage of trials correct
Measured: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Cognitive inhibition performance task
Addiction Stroop Task, reaction time to drug vs. neutral words presented in different colors
Measured: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Vigilance performance task
Psychomotor Vigilance Task (PVT) average reaction time
Measured: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Hypothetical drug purchasing questionnaire
Intensity and elasticity of drug demand. This is measured by having the participant make a series of independent choices as to how many drug units s/he will purchase across a range of (low to high) unit prices. Demand intensity is the drug purchase amount at the lowest non-zero price. Demand intensity is the calculated point on the price/purchasing curve where the slope (in log/log space) equals -1 (i.e. 'tipping point' where purchasing decreases more rapidly than the rate of increase in drug price).
Measured: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Preference for natural reinforcement choice procedure
Number of choices for money vs. avoiding listening to soundtrack of crying babies
Measured: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Monetary delay discounting questionnaire
Participants are asked to make a series of independent choices (preferences) for delayed larger amounts of money vs. smaller immediate amounts of money. The outcome is the rate at which future choice value is discounted, measured by area under the time-delay curve
Measured: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Respiration rate
Breaths per minute, measured by behavioral observation
Measured: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Oxygen saturation
Percentage oxygen saturation, measured by photoplethysmograph
Measured: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Heart rate
Pulse rate (beats per minute), measured by photoplethysmograph
Measured: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Blood pressure
Systolic and diastolic blood pressure (mm Hg)
Measured: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Pupil diameter
Pupil size (mm), measured by digital photography
Measured: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Drug effect visual analog scale (VAS) ratings
0-100 scale ratings of alert, difficulty concentrating, clumsy, confused, forgetful, blurred vision, dizzy, heaviness in limbs, mellow, yawning, stimulated, sedated, sleepy, tired, energetic, self-confident, dreamy, floating, sluggish, tingling, high, liking, good drug effect, bad drug effect
Measured: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Drug craving visual analog scale (VAS) ratings
0-100 scale rating of "want to take drug again", "desire to use", and "craving" for opioids, sedatives, alcohol, cigarettes, marihuana, and cocaine
Measured: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Sleep efficiency
Percentage of sleep time (time asleep divided by time in bed), measured using WatchPat device
Measured: difference from placebo condition, measured on an outpatient basis during the evening after each laboratory drug administration; measured after each of the 6 laboratory sessions over about 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start13 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid AbuseStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Repeated measures, placebo-controlled, randomized crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Ford Health System
- Responsible party
- Principal investigator, Mark Greenwald, PhD, Wayne State University
- Investigators
- Mark K Greenwald, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006079
- Sponsor's protocol ID
- IRB-21-07-3844
- Acronym
- MAP
- Status last verified
- Dec 2025
- First submitted
- 4 Aug 2021
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid/Benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies - Study 3
- ClinicalTrials.gov ID
- NCT05006079
- Acronym / sponsor ID
- MAP / IRB-21-07-3844
- Conditions
- Opioid Abuse, Benzodiazepine Abuse, Polysubstance Abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- Henry Ford Health System
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Aug 2021 (actual)
- 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.
In this study, the investigators will measure affective, neurocognitive and behavioral outcomes related to chronic use of opioids and benzodiazepines (screening phase), and in response to the administration of the opioid morphine, the benzodiazepine alprazolam, morphine then alprazolam, alprazolam then morphine, morphine+alprazolam simultaneously, and placebo (laboratory pharmacology experiment). The latter will enable the investigators to assess the effects of an opioid alone, benzodiazepine alone, concurrent and simultaneous administration of opioid+benzodiazepine, relative to a placebo control.
Detailed description
The investigators propose that benzodiazepine/opioid polysubstance abuse is perpetuated by a dual-deficit in affective/hedonic regulation (difficulties modulating emotional reactions relative to the context and the person's long-term goals). Furthermore, the investigators propose that this dual-deficit biases neurocognition (interferes with executive function) and behaviors (guided by negative reinforcement processes such that polysubstance use acutely blunts aversive states and directs actions away from natural rewards). The scientific premise for this project builds on George Koob's foundational concept that addiction is a 'reward-deficit/stress-surfeit disorder'. There is an urgent need to obtain clinical pharmacology and mechanistic data to test this hypothesis of dual-deficit in affective/hedonic regulation. This study will use human laboratory methods to test affective, neurocognitive and behavioral mechanisms that maintain benzodiazepine/opioid polysubstance abuse.
The screening phase of this human laboratory study will include measures of affective dysregulation related to benzodiazepine/opioid polysubstance use behaviors. These include distress tolerance, pain sensitivity and nocebo responding, and biomarkers (e.g. plasma cortisol). Also, the investigators will include behavioral measures of drug and non-drug reinforcement (e.g. economic simulations of price elasticity of alprazolam and morphine) and neurocognition (e.g. drug attentional bias, response inhibition, cognitive flexibility).
During the pharmacology study the investigators will administer oral placebo, morphine alone and alprazolam doses alone, as well as morphine and alprazolam sequentially (in counterbalanced order) and simultaneously. Following each drug administration, the investigators will measure responses in affective (e.g. anxiety levels, distress tolerance), neurocognitive (e.g. executive function, learning) and behavioral domains (e.g. impulsivity, psychomotor function, reinforcer preferences). The lab study is highly significant because we lack prospective, controlled, dose-response studies that identify whether opioids, benzodiazepines, and their combination modulate core phenotypes that underlie this harmful polysubstance abuse. Testing effects of both sequential and simultaneous benzodiazepine/opioid administration within the same individuals will establish a firm foundation for understanding which phenotypes are sensitive to disruption and may respond to treatment.
Findings from this study will help to focus clinical assessment and identify mechanisms that maintain benzodiazepine/opioid polysubstance abuse, toward the development of novel medication-assisted, evidence-based psychosocial interventions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
- Model description
- Repeated measures, placebo-controlled, randomized crossover
| Arm | Type | Receives |
|---|---|---|
| Placebo drug | Placebo comparator | Drug: PlaceboLactose, administered both at 9:30 am and 12:00 pm |
| Morphine alone | Active comparator | Drug: Morphine15mg immediate-release oral morphine, administered both at 9:30 am and 12:00 pm |
| Alprazolam alone | Active comparator | Drug: Alprazolam0.25mg oral alprazolam, administered at both 9:30 am and 12:00 pm |
| Morphine then alprazolam | Active comparator | Drug: Morphine, Drug: Alprazolam15mg oral morphine administered at 9:30 am, then 0.25mg oral alprazolam administered at 12:00 pm |
| Alprazolam then morphine | Active comparator | Drug: Morphine, Drug: Alprazolam0.25mg oral alprazolam administered at 9:30 am, then 15mg oral morphine administered at 12:00 pm |
| Morphine+alprazolam simultaneously | Active comparator | Drug: Morphine, Drug: Alprazolammorphine 15mg + 0.25mg alprazolam at 9:30 am, then morphine 15mg + 0.25mg alprazolam at 12:00 pm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- must self-report past 10-year experience taking opioid and sedative drugs (for therapeutic or non-therapeutic reasons), but not necessarily at the same time. As an alternative to the sedative drug exposure requirement, participants must have used alcohol on at least 3 separate days during the past month. Participants may have current mild- or moderate-severity Opioid Use Disorder or current mild- or moderate-severity Sedative Use Disorder;
- must not be seeking treatment for their substance use problems;
- must be in current good overall health
Key exclusion criteria (13 listed)
- meet DSM-5 criteria for current psychosis, bipolar disorder, or severe depression (i.e. severe psychiatric disorder);
- meet DSM-5 criteria for severe substance use disorder for any substance (e.g. Sedative, Opioid, Alcohol);
- past-month benzodiazepine or opioid prescription (which would suggest daily use, tolerance, or withdrawal upon cessation);
- report of past-year any-drug overdose or suicide attempt/ideation;
- exhibit cognitive impairment (IQ < 80 on the Shipley Institute of Living Scale);
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 |
|---|---|---|
| Morphineimmediate release oral 15mg dose | Drug | Alprazolam then morphine, Morphine alone, Morphine then alprazolam, Morphine+alprazolam simultaneously |
| Alprazolamoral 0.25mg dose | Drug | Alprazolam alone, Alprazolam then morphine, Morphine then alprazolam, Morphine+alprazolam simultaneously |
| PlaceboLactose | Drug | Placebo drug |
Primary outcome
State anxiety
Time frame: within-session peak change from pre-drug baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
State Trait Anxiety Inventory - state anxiety scale total score
Positive affect
Time frame: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Positive and Negative Affect Scale-Short Form (PANAS-SF) positive affect scale score
Negative affect
Time frame: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Positive and Negative Affect Scale-Short Form (PANAS-SF) negative affect scale score
16 secondary outcomes
Symbol matching performance task
Time frame: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Impulsivity performance task accuracy
Time frame: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Cognitive flexibility performance task
Time frame: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Cognitive inhibition performance task
Time frame: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Vigilance performance task
Time frame: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Hypothetical drug purchasing questionnaire
Time frame: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Preference for natural reinforcement choice procedure
Time frame: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Monetary delay discounting questionnaire
Time frame: difference from placebo condition, measured within each session at 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Respiration rate
Time frame: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Oxygen saturation
Time frame: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Heart rate
Time frame: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Blood pressure
Time frame: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Pupil diameter
Time frame: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Drug effect visual analog scale (VAS) ratings
Time frame: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Drug craving visual analog scale (VAS) ratings
Time frame: within-session peak change from baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks
Sleep efficiency
Time frame: difference from placebo condition, measured on an outpatient basis during the evening after each laboratory drug administration; measured after each of the 6 laboratory sessions over about 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
Mark K 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 2 study testing Morphine and Alprazolam in people with Opioid Abuse and Benzodiazepine Abuse, 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 3 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark K Greenwald, PhD (313-993-3965, mgreen@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State anxiety (time frame: within-session peak change from pre-drug baseline to 15-120 min post-drug 1 and 15-240 min post-drug 2 administration; measured in each of the 6 laboratory sessions over about 3 weeks). The study lists 3 primary outcomes in all. 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 30 Dec 2025.