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New treatment option for Opioid Abuse
Official title Opioid/Benzodiazepine Polydrug Abuse: Aim 3
ClinicalTrials.gov ID: NCT05006079
What this study is testing
What is Morphine?
Morphine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for opioid abuse.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- must self-report past 10-year experience taking opioid and sedative drugs (for therapeutic or non-therapeutic reasons), but not necessarily at the...
- must not be seeking treatment for their substance use problems;
- must be in current good overall health
You likely can't join if
- 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 people);
See the full eligibility criteria
- 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...
- must not be seeking treatment for their substance use problems;
- must be in current good overall health
- 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 people);
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.