Psilocybin for Methamphetamine Use Disorder
ConditionMethamphetamine Use Disorder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeter Hendricks
About this trial
This trial tests whether psilocybin-assisted treatment can help adults stop using methamphetamine. Participants receive a single oral dose of psilocybin during a supervised session, paired with brief cognitive behavioral therapy, and are followed for up to six months. The study is supported by the HEAL Initiative (https://www.nih.gov/heal).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18+
DSM-5 moderate or severe Methamphetamine Use Disorder
Severity of Dependence Scale score ≥ 4
Methamphetamine use on more than 7 of the past 30 days and more than one positive urine test before randomization
Disqualifiers
Pregnancy or breastfeeding, or not using effective contraception
Current psychiatric diagnoses other than a mild substance use disorder or tobacco/nicotine use disorder
Current hypertension (>140/90 at rest)
Regular use of centrally acting serotonergic medications or MAO inhibitors (washout/re-screen permitted)
Trial design
Design model
Parallel
Treatments tested in this trial
Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct).
DrugThe specific doses (in mg) are intentionally omitted from this registration during the conduct of the trial to preserve masking and reduce expectancy effects. The doses will be disclosed when results are reported after primary completion, by which point participants have been debriefed.
Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).
BehavioralManualized CBT, adapted from Hendricks et al. (2026; https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2848757)
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Psilocybin, Dose AExperimental treatment 2 interventions
Group B: Psilocybin, Dose BExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Abstinent Days
Percentage of days abstinent from methamphetamine (Timeline Followback, urine-confirmed); possible range is 0% to 100%, with higher scores reflecting more abstinence.
Time frame
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).Secondary outcomes
1
Complete Abstinence
Complete abstinence from methamphetamine (Timeline Followback, urine-confirmed); a dichotomous (yes or no) outcome where no use whatsoever during the assessment period is coded as "yes" and any use at all during the assessment period is coded as "no."
Time frame
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).2
Methamphetamine Use Disorder in Remission
Modified DSM-5 Methamphetamine Use Disorder in early remission (SCID-5); a dichotomous (yes or no) outcome where those who meet DSM-5 criteria for Methamphetamine Use Disorder in early remission are coded as "yes" and those who do not meet DSM-5 criteria for Methamphetamine Use Disorder in early remission are coded as "no."
Time frame
30/90-day (UG3), 30/90/180-day (UH3)3
Health-related Quality of Life
Health-related quality of life as measured by the RAND-36 self-report measure. The RAND-36 contains 8 primary health scales (Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Social functioning, Emotional well-being \[mental health\], Energy/fatigue \[vitality\], Bodily pain, and General health perception) and 2 summary scales (Physical Health Summary and Mental Health Summary) with possible scores for each scale ranging from 0 to 100. Higher scores represent better health states and outcomes.
Time frame
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).4
Self-perceived Quality of Life
Self-perceived quality of life as measured by the WHOQOL-BREF self-report measure. This measure includes 4 scales (Physical, Psychological, Social, and Environment), each with a possible range from 0 to 100. Higher scores indicate a better quality of life.
Time frame
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).Other outcomes
1
Meaning in Life
Meaning in life as measured by the Meaning in Life questionnaire. This questionnaire yields 2 scales: Search for Meaning and Presence of Meaning. Scores range from 1 to 7 for both scales with greater scores reflecting exploration for existential significance (Search for Meaning) and conviction that one's life is rich with purpose (Presence for Meaning).
Time frame
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).2
Psychosocial-Spiritual Well-Being
Psychosocial-spiritual well-being as measured by the NIH Healing Experience of All Life Stressors Short Form (NIH-HEALS-SF). The NIH-HEALS-SF yields 3 scales: Deepened Connection, Active Reflection \& Introspection, and Profound Trust \& Acceptance. Total scores for each scale range from 1 to 5 (if computing a mean) or 3 to 15 (if computing a sum for comparison to published data). Higher scores reflect a stronger capacity for psychological resilience, emotional healing, and spiritual well-being while facing major life stressor.
Time frame
Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peter Hendricks
Lead sponsor
University of Alabama at Birmingham
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov
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