RECRUITING

Opioid/Benzodiazepine Polydrug Abuse: Aim 3

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Opioid/Benzodiazepine Polydrug Abuse: Integrating Research on Mechanisms, Treatment and Policies - Study 3

Quick Facts

Study Start:2024-03-13
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05006079

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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;
  2. * must not be seeking treatment for their substance use problems;
  3. * must be in current good overall health
  1. * meet DSM-5 criteria for current psychosis, bipolar disorder, or severe depression (i.e. severe psychiatric disorder);
  2. * meet DSM-5 criteria for severe substance use disorder for any substance (e.g. Sedative, Opioid, Alcohol);
  3. * past-month benzodiazepine or opioid prescription (which would suggest daily use, tolerance, or withdrawal upon cessation);
  4. * report of past-year any-drug overdose or suicide attempt/ideation;
  5. * exhibit cognitive impairment (IQ \< 80 on the Shipley Institute of Living Scale);
  6. * neurological, cardiovascular, pulmonary, or systemic diseases (see specific exclusionary conditions under Protection of Human Subjects);
  7. * body mass index \> 38 kg/m2;
  8. * females who are pregnant (urine), lactating or heterosexually active (self-report) and not using medically approved birth control;
  9. * treatment with methadone, buprenorphine or naltrexone;
  10. * past 30-day use of contraindicated medications;
  11. * alcohol-positive breath sample (\>.02% breath alcohol concentration);
  12. * urine sample positive for methadone, cocaine, amphetamines, or barbiturates (\<300 ng/ml)
  13. * intolerance of lactose

Contacts and Locations

Study Contact

Mark K Greenwald, PhD
CONTACT
313-993-3965
mgreen@med.wayne.edu
Heidi Aguas
CONTACT
313-993-3960
gh7962@wayne.edu

Principal Investigator

Mark K Greenwald, PhD
PRINCIPAL_INVESTIGATOR
Wayne State University

Study Locations (Sites)

Tolan Park Medical Building
Detroit, Michigan, 48201
United States

Collaborators and Investigators

Sponsor: Wayne State University

  • Mark K Greenwald, PhD, PRINCIPAL_INVESTIGATOR, Wayne State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-13
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-03-13
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Abuse
  • Benzodiazepine Abuse
  • Polysubstance Abuse