Methamphetamine Use Disorder, Human Immunodeficiency Virus (HIV)
Conditions
Keywords
methamphetamine use disorder, HIV, methamphetamine, psilocybin, amphetamine-related disorders, stimulant use disorder, people with HIV, psychedelics, psychedelic-assisted therapy
Brief summary
The goal of this clinical trial is to learn whether it is possible to use psilocybin in combination with motivational support therapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in people with HIV who are seeking to stop using methamphetamine. The main questions it aims to answer are: * Do people with HIV and MeUD find psilocybin with motivational support therapy feasible and acceptable as a potential treatment? * Is psilocybin safe and tolerable among people with HIV and MeUD? Participants will: * Be randomly assigned to receive a single monitored dose of either 25 mg (higher dose) or 5 mg (lower dose) psilocybin * Have 3 preparation and 3 integration motivational support therapy visits before and after the psilocybin dosing session. * Report their methamphetamine use prior to, during, and up to 3 months following the intervention * Optionally receive one additional open-label 25 mg psilocybin session after the 4-week assessment, if eligible
Interventions
DRUGPsilocybin 5 mg
Single oral 5 mg dose of psilocybin, administered as a capsule under direct observation during a monitored \~8-hour dosing session. Serves as the low-dose active control during the double-blind randomized phase.
DRUGPsilocybin 25 mg
Single oral 25 mg dose of psilocybin, administered as a capsule under direct clinical observation during a monitored \~8-hour dosing session. Given as the higher dose during the double-blind randomized phase and as the dose used in the optional open-label session.
BEHAVIORALMotivational Support
Manualized motivational support delivered by trained facilitators, adapted from the NIAAA Project MATCH MET manual. During the double-blind phase, participants attend 3 preparatory talk therapy sessions before dosing and 3 integration talk therapy sessions after dosing; the optional open-label session is accompanied by an additional 1 preparatory and 3 integration talk therapy sessions before and after the second (open-label) dose. Sessions support rapport, intention-setting, psilocybin psychoeducation and safety, and post-session meaning-making.
Sponsors
Nicky Mehtani, MD, MPH
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Age 25 to 64 * Diagnosed with HIV at least 3 months ago * Moderate-to-severe methamphetamine use disorder * Uses methamphetamine regularly and identifies it as their primary drug * Has a goal of quitting methamphetamine use * Able and willing to abstain from methamphetamine and other non-prescribed drugs for at least 24 hours prior to and throughout psilocybin dosing sessions * Currently living indoors with stable housing anticipated for the duration of the study * Has a text-capable cellphone * Willing to use highly effective contraception and not donate sperm throughout the study * Able to participate in study procedures in English
Exclusion criteria
* History of any primary psychotic disorder (e.g., schizophrenia or schizoaffective disorder), bipolar I disorder, or certain other psychiatric conditions as determined by study assessment * Current moderate-to-severe opioid, alcohol, or sedative use disorder (Note: people on stable doses of buprenorphine or methadone may be eligible) * Currently taking certain medications that may interact with psilocybin * Recent use of a psychedelic drug * Certain significant heart, liver, or kidney conditions * Uncontrolled high blood presure (i.e., \>150/90 mmHg) * History of stroke or seizure in the past year * Current pregnancy or breastfeeding * Current involvement in the criminal legal system that would be expected to interfere with study participation * Current or planned enrollment in a contingency management program or another investigational substance use treatment trial within the past month Note: Additional eligibility criteria apply. Certain criteria and thresholds are not listed here to preserve the scientific integrity of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Efficiency | Screening to Baseline (approximately 35 days) | Proportion of participants who undergo in-person screening who are fully enrolled in the study and initiate treatment. |
| Dosing Completion | Baseline to Dosing Visit (approximately 10 days) | Proportion of enrolled participants who receive psilocybin dosing. |
| Retention | Dosing Visit to Visit 9 (approximately 28 days) | Proportion of participants receiving psilocybin who complete the end-of-double-blind-period study visit. |
| Acceptability | Visit 9, approximately 38 days | Scores on an end-of-treatment acceptability questionnaire. |
| Adverse Events | Dosing Visit to Visit 9 (approximately 28 days) | Number of participants who experience treatment-emergent adverse events between initial psilocybin dosing and the end-of-double-blind-period visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Methamphetamine Use (TLFB) | Baseline to Visit 9 (approximately 38 days) | Change from baseline in self-reported past-month days of methamphetamine use, assessed by Timeline Followback (TLFB), at Day 28 post-dose. |
Countries
United States
Contacts
CONTACTEliza Banbury, BA
PRINCIPAL_INVESTIGATORNicky J. Mehtani, MD, MPH
University of California, San Francisco
Outcome results
None listed