Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use

Part of paid clinical trials in Houston, Texas.

Sponsor
Christopher D. Verrico
Study ID
NCT07218549
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Placebo — DRUG
    Placebo: A single dose of placebo to match kratom (over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.
  • Oxycodone HCl — DRUG
    Active Control: A single 30 mg dose of oxycodone (1 X 30 mg tablet over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.
  • Kratom 8g — DRUG
    Kratom: A single 8 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
  • Kratom 12g — DRUG
    Kratom: A single 12 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
  • Kratom 16g — DRUG
    Kratom: A single 16 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
  • Kratom 4g — DRUG
    Kratom: A single 4 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Study Details

The purpose of this study is to understand how kratom affects people. In this study, kratom will be compared with another substance and a placebo (an inactive substance). Researchers will also study how the substances move through and affect the body. This includes examining how the body absorbs, processes, and eliminates the drug (pharmacokinetics), as well as how the drug affects the body and how it may make you feel (pharmacodynamics). The information collected will help researchers better understand the effects and potential risks of kratom.

Key Dates

Start date
May 1, 2026
Status verified
Oct 2025
Primary completion
Dec 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Placebo Comparator: Treatment Sequence A
    Placebo: A single dose of placebo to match kratom (over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.
  • Active Comparator: Treatment Sequence B
    Active Control: A single 30 mg dose of oxycodone (1 X 30 mg tablet over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.
  • Active Comparator: Treatment Sequence C
    Kratom: A single 4 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
  • Experimental: Treatment Sequence D
    Kratom: A single 8 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
  • Experimental: Treatment Sequence E
    Kratom: A single 12 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.
  • Experimental: Treatment Sequence F
    Kratom: A single 16 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Primary Outcome Measure

Drug Liking Visual Analog Scale [ Time Frame: From Treatment Week 1 to Treatment Week 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Michael E DeBakey VA Medical CenterHoustonTexas77030
Christopher D Verrico, PhD Pharmacology
[email protected]
713-791-1414
Adetola O Vaughan, MA Psychology
[email protected]
713-791-1414

Find similar trials in Houston, TX

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Michael E DeBakey VA Medical Center· Houston, TX

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