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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
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
Awards & highlights

MAP Trial 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.Check my eligibility
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.See study design
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.

MAP Trial 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

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

MAP Trial Design

6Treatment groups
Active Control
Placebo Group
Group I: Morphine aloneActive Control1 Intervention
15mg immediate-release oral morphine, administered both at 9:30 am and 12:00 pm
Group II: Alprazolam aloneActive Control1 Intervention
0.25mg oral alprazolam, administered at both 9:30 am and 12:00 pm
Group III: Morphine then alprazolamActive Control2 Interventions
15mg oral morphine administered at 9:30 am, then 0.25mg oral alprazolam administered at 12:00 pm
Group IV: Alprazolam then morphineActive Control2 Interventions
0.25mg oral alprazolam administered at 9:30 am, then 15mg oral morphine 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
307 Previous Clinical Trials
108,755 Total Patients Enrolled
Henry Ford Health SystemOTHER
300 Previous Clinical Trials
2,100,103 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
260 Total Patients Enrolled

Media Library

Alprazolam (Benzodiazepine) Clinical Trial Eligibility Overview. Trial Name: NCT05006079 — Phase 2
Opioid Addiction Research Study Groups: Placebo drug, Morphine alone, Alprazolam alone, Morphine then alprazolam, Alprazolam then morphine, 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do both Alprazolam and morphine have FDA approval?

"Alprazolam then morphine scored a 2 for safety. This is because, although there are Phase 2 trials underway testing its efficacy, currently there is only data supporting its safety."

Answered by AI

Are there still available positions for research volunteers?

"Indeed, this is an ongoing study that has most recently been updated on June 23rd, 2022. The clinical trial originally posted on June 15th of the same year and is currently recruiting for 24 subjects at 1 location."

Answered by AI

What are the aims of this clinical trial?

"The primary outcome of this trial, which will be assessed over a 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 time frame is Negative affect. Secondary outcomes include Cognitive flexibility performance task (i.e. Wisconsin Card Sorting Task percentage of trials correct), Cognitive inhibition performance task (i.e Addiction Stroop Task reaction time to drug vs. neutral words presented in different colors), and Preference for natural reinforcement choice procedure (i.e Number of choices for money vs. avoiding"

Answered by AI

Would this research be open to participants that are over 30 years old?

"This trial's minimum age limit is 18 and the maximum age an enrolled patient can be is 60."

Answered by AI

Why are Alprazolam and morphine often given together?

"Alprazolam and morphine can be used together to mitigate the effects of panic attacks, pain, and anxiety caused by therapeutic procedures."

Answered by AI

Are there any restrictions for people who want to enroll in this research project?

"In order to participate in this research, individuals must have a history of benzodiazepine use and be between 18-60 years old. Up to 24 patients will be accepted into the clinical trial."

Answered by AI

Is Alprazolam's usage in medicine unique compared to other drugs?

"Currently, there are 64 ongoing studies studying the combination of Alprazolam and morphine. Of these, 18 are in Phase 3. Most of the trials for Alprazolam then morphine are being conducted in Amersfoort, Noord Holland, but there are 292 locations running studies for Alprazolam then morphine."

Answered by AI

How many people have signed up to be a part of this experiment?

"The most recent information on clinicaltrials.gov affirms that this study is looking for 24 participants at a single site. The trial was first announced on 6/15/2022 and updated on 6/23/2022."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
Tolan Park Medical Building
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

How responsive is this trial?

Most responsive sites:
  1. Tolan Park Medical Building: < 48 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
~16 spots leftby Aug 2025