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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 1, 2026

Primary Completion Date

December 31, 2028

Study Completion Date

May 31, 2029

Conditions
Opioid UseSubstance Use DisordersOpioid Analgesia
Interventions
DRUG

Placebo

Placebo: A single dose of placebo to match kratom (over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.

DRUG

Oxycodone HCl

Active Control: A single 20 mg dose of oxycodone (1 X 20 mg tablet over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.

DRUG

Oxycodone HCl

Active Control: A single 40 mg dose of oxycodone (2 X 20 mg tablets over-encapsulated placebo in 32 opaque 00 capsules) will be administered orally.

DRUG

Kratom 8

Kratom: A single 8 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

DRUG

Kratom 12g

Kratom: A single 12 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

DRUG

Kratom 16g

Kratom: A single 16 g dose of kratom (in 32 opaque 00 capsules) will be administered orally.

Trial Locations (1)

77030

Michael E DeBakey VA Medical Center, Houston

All Listed Sponsors
collaborator

Baylor College of Medicine

OTHER

lead

Christopher D. Verrico

OTHER