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Benzodiazepine

Opioids + Benzodiazepines for Substance Abuse (MAP Trial)

Phase 2
Recruiting
Led By Mark K Greenwald, PhD
Research Sponsored by Wayne State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Past-month benzodiazepine or opioid prescription (which would suggest daily use, tolerance, or withdrawal upon cessation)
Meet DSM-5 criteria for current psychosis, bipolar disorder, or severe depression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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

Summary

This trial will study the effects of opioids and benzodiazepines on cognition, emotions, and behavior.

Who is the study for?
This trial is for adults who have used opioids and sedatives in the past five years, not seeking treatment, and are generally healthy. They may have mild to moderate opioid or sedative use disorder but can't be severely overweight, pregnant, using certain drugs, or have severe mental health issues.
What is being tested?
The study tests how morphine (an opioid) and alprazolam (a benzodiazepine) affect emotions, thinking, and behavior when taken alone or together compared to a placebo. It aims to understand the impact of these substances on chronic users.
What are the potential side effects?
Possible side effects include drowsiness, confusion, addiction potential with long-term use; slowed breathing; impaired coordination; mood changes; memory problems; risk of overdose especially when combined.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been prescribed benzodiazepines or opioids in the past month.
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I have been diagnosed with psychosis, bipolar disorder, or severe depression.
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I am not pregnant, breastfeeding, or if sexually active, I use birth control.
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I am currently taking methadone, buprenorphine, or naltrexone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Negative affect
Positive affect
State anxiety
Secondary study objectives
Blood pressure
Cognitive flexibility performance task
Cognitive inhibition performance task
+13 more

Trial Design

6Treatment groups
Active Control
Placebo Group
Group I: Alprazolam then morphineActive Control2 Interventions
0.25mg oral alprazolam administered at 9:30 am, then 15mg oral morphine administered at 12:00 pm
Group II: Morphine aloneActive Control1 Intervention
15mg immediate-release oral morphine, administered both at 9:30 am and 12:00 pm
Group III: Alprazolam aloneActive Control1 Intervention
0.25mg oral alprazolam, administered at both 9:30 am and 12:00 pm
Group IV: Morphine then alprazolamActive Control2 Interventions
15mg oral morphine administered at 9:30 am, then 0.25mg oral alprazolam administered at 12:00 pm
Group V: Morphine+alprazolam simultaneouslyActive Control2 Interventions
morphine 15mg + 0.25mg alprazolam at 9:30 am, then morphine 15mg + 0.25mg alprazolam at 12:00 pm
Group VI: Placebo drugPlacebo Group1 Intervention
Lactose, administered both at 9:30 am and 12:00 pm

Find a Location

Who is running the clinical trial?

Wayne State UniversityLead Sponsor
314 Previous Clinical Trials
110,873 Total Patients Enrolled
Henry Ford Health SystemOTHER
311 Previous Clinical Trials
2,176,342 Total Patients Enrolled
1 Trials studying Opioid Addiction
200 Patients Enrolled for Opioid Addiction
Mark K Greenwald, PhDPrincipal InvestigatorWayne State University
5 Previous Clinical Trials
177 Total Patients Enrolled

Media Library

Alprazolam (Benzodiazepine) Clinical Trial Eligibility Overview. Trial Name: NCT05006079 — Phase 2
Opioid Addiction Research Study Groups: Alprazolam then morphine, Placebo drug, Morphine alone, Alprazolam alone, Morphine then alprazolam, Morphine+alprazolam simultaneously
Opioid Addiction Clinical Trial 2023: Alprazolam Highlights & Side Effects. Trial Name: NCT05006079 — Phase 2
Alprazolam (Benzodiazepine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05006079 — Phase 2
~12 spots leftby Aug 2025
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