MedPath

Opioid/Benzodiazepine Polydrug Abuse: Aim 3

Phase 2
Recruiting
Conditions
Opioid Abuse
Benzodiazepine Abuse
Polysubstance Abuse
Registration Number
NCT05006079
Lead Sponsor
Wayne State University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
24
Inclusion Criteria

Inclusion Criteria:<br><br> - must self-report past 10-year experience taking opioid and sedative drugs (for<br> therapeutic or non-therapeutic reasons), but not necessarily at the same time. As an<br> alternative to the sedative drug exposure requirement, participants must have used<br> alcohol on at least 3 separate days during the past month. Participants may have<br> current mild- or moderate-severity Opioid Use Disorder or current mild- or<br> moderate-severity Sedative Use Disorder;<br><br> - must not be seeking treatment for their substance use problems;<br><br> - must be in current good overall health<br><br>Exclusion Criteria:<br><br> - meet DSM-5 criteria for current psychosis, bipolar disorder, or severe depression<br> (i.e. severe psychiatric disorder);<br><br> - meet DSM-5 criteria for severe substance use disorder for any substance (e.g.<br> Sedative, Opioid, Alcohol);<br><br> - past-month benzodiazepine or opioid prescription (which would suggest daily use,<br> tolerance, or withdrawal upon cessation);<br><br> - report of past-year any-drug overdose or suicide attempt/ideation;<br><br> - exhibit cognitive impairment (IQ < 80 on the Shipley Institute of Living Scale);<br><br> - neurological, cardiovascular, pulmonary, or systemic diseases (see specific<br> exclusionary conditions under Protection of Human Subjects);<br><br> - body mass index > 38 kg/m2;<br><br> - females who are pregnant (urine), lactating or heterosexually active (self-report)<br> and not using medically approved birth control;<br><br> - treatment with methadone, buprenorphine or naltrexone;<br><br> - past 30-day use of contraindicated medications;<br><br> - alcohol-positive breath sample (>.02% breath alcohol concentration);<br><br> - urine sample positive for methadone, cocaine, amphetamines, or barbiturates (<300<br> ng/ml)<br><br> - intolerance of lactose

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
State anxiety;Positive affect;Negative affect
Secondary Outcome Measures
NameTimeMethod
Symbol matching performance task;Impulsivity performance task accuracy;Cognitive flexibility performance task;Cognitive inhibition performance task;Vigilance performance task;Hypothetical drug purchasing questionnaire;Preference for natural reinforcement choice procedure;Monetary delay discounting questionnaire;Respiration rate;Oxygen saturation;Heart rate;Blood pressure;Pupil diameter;Drug effect visual analog scale (VAS) ratings;Drug craving visual analog scale (VAS) ratings;Sleep efficiency
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