Methamphetamine Use DisorderPhase 2NCT07774702
Psilocybin for Methamphetamine Use Disorder
A Phase 2 study testing Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct). and Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions). in people with Methamphetamine Use Disorder, run by Peter Hendricks at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methamphetamine Use Disorder
- What is being tested?
- Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct). and Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 1 Feb 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- A goal of complete abstinence on the Thoughts About Abstinence questionnaire
- Able to read, write, and speak English
Show all 9Show fewer
- A friend or family member available for post-session release
- Good general health by history and physical
- Confirmed pre-dose abstinence of at least 24 hours (clinically assessed)
Who cannot join
- 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)
- Personal history of any psychotic or bipolar I/II disorder, or a first- or second-degree relative with such
- Current suicidal or homicidal ideation
- Plan to relocate within 6 months
- Psychedelic use in the past 3 years, more than 3 lifetime psychedelic occasions, more than 3 lifetime ketamine or MDMA occasions, or any prior 5-MeO-DMT or ibogaine use
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Seher Premani, MPH, 205-975-7721, spremani@uab.edu
Noah Sweat, BS, 205-996-0212, nsweat@uabmc.edu
About this study
Official title: Psilocybin in the Treatment of Methamphetamine Use Disorder
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).
Read the detailed description
Single-site, phased UG3/UH3 randomized, quadruple-masked, parallel-group controlled trial (target N = 42). Participants are randomized 1:1 to a single administration of psilocybin at one of two dose levels, each delivered with a manualized platform of two preparation and two integration sessions. The specific doses are withheld in this registration during the conduct of the trial to preserve masking and reduce expectancy effects, and will be reported with results. The UG3 phase (n = 12) establishes feasibility and safety; the UH3 phase (n = 30) expands enrollment with longer follow-up. Support is provided by the HEAL Initiative (https://www.nih.gov/heal).
- Conditions
- Methamphetamine Use Disorder
- Being tested
- Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct)., Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).
- Keywords
- psilocybin, methamphetamine, HEAL Initiative, psychedelic-assisted therapy, substance use disorder
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct).Drug
The 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).Behavioural
Manualized CBT, adapted from Hendricks et al. (2026; https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2848757)
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin, Dose A | Experimental | Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct). Receives: Drug: Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct).; Behavioral: Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions). |
| Psilocybin, Dose B | Experimental | Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct). Receives: Drug: Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct).; Behavioral: Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinent Days
Percentage of days abstinent from methamphetamine (Timeline Followback, urine-confirmed); possible range is 0% to 100%, with higher scores reflecting more abstinence.
Measured: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Secondary outcomes (11)
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."
Measured: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
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."
Measured: 30/90-day (UG3), 30/90/180-day (UH3)
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.
Measured: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
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.
Measured: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Craving
Craving, as measured by the Stimulant Craving Questionnaire-Brief (STCQ-Brief), a 10-item self-report tool measuring present-moment craving for stimulants. A score is calculated by averaging all 10 items, with a possible range of 0 to 6. Higher mean scores reflect more severe craving.
Measured: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Withdrawal
Methamphetamine withdrawal as measured by the Amphetamine Cessation Symptom Assessment (ACSA), a 16-item clinical rating tool used to measure the severity of amphetamine withdrawal symptoms over the preceding 24 hours. Scores range from 0 to 64, with higher scores reflecting more severe withdrawal symptoms.
Measured: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Severity of Dependence
Severity of methamphetamine dependence, as measured by the Stimulant Use Disorder Severity Scale (StUDSS). The StUDSS is a new patient-reported outcome instrument measuring the severity of symptoms for stimulant use disorder. Total symptom severity is based on a sum of all items, with a possible range of 0 to 44. Higher scores reflect more severe dependence. The StUDSS also yields a categorical severity rating based on total criteria count: Mild (2 or 3 criteria), Moderate (4 or 5 criteria), or Severe (6 or more criteria).
Measured: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Mystical-type Experience
Mystical-type experience during the day of dosing as measured by the Mystical Experience Questionnaire (MEQ). The MEQ yields 4 scales: Unity, Positive Mood, Transcendence of Time and Space, and Ineffability. Possible scores for each scale range from 0 to 5 and greater scores reflect higher intensity and greater depth of the mystical experience.
Measured: Day of dosing (≈7 hours)
Challenging Experience
Challenging experience during the day of dosing as measured by the Challenging Experience Questionnaire (CEQ). The CEQ yields 7 scales: Fear, Grief, Physical Distress, Insanity, Isolation, Death, and Paranoia. Possible scores range from 0 to 5, with greater scores reflecting higher intensity and more severe degree of psychological or physical distress during the experience
Measured: Day of dosing (≈7 hours)
Emotional Breakthrough
Emotional breakthrough on the day of dosing as measured by the Emotional Breakthrough Inventory (EBI). The EBI is a 6-item scale scored using a 0 to 100 Visual Analogue Scale (VAS) for each item. The total overall score is calculated as the sum of all six items, yielding a total summed score ranging from 0 to 600. Greater scores on the EBI reflect a deeper, more complete sense of psychological resolution and catharsis.
Measured: Day of dosing (≈7 hours)
Psychological Insight
Psychological insight during the day of dosing as measured by the Psychological Insight Questionnaire (PIQ). The PIQ measure insight on 2 scales: Avoidance and Maladaptive Patterns Insights and Goals and Adaptive Patterns Insights. Scores on the 2 scales range from 0 to 5, with greater scores representing a higher intensity of acute psychological realizations gained during the experience.
Measured: Day of dosing (≈7 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2032 (estimated)
- Study completion1 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Hendricks
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Peter Hendricks, University of Alabama at Birmingham
- Investigators
- Peter S Hendricks, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774702
- Sponsor's protocol ID
- IRB-300017113
- Other IDs
- IND 121000, 1UG3DA067126
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data, metadata, and a data dictionary will be shared through an NIH-designated repository accessible via the HEAL Data Ecosystem, consistent with the study's Data Management and Sharing Plan and the HEAL Public Access and Data Sharing Policy.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin in the Treatment of Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT07774702
- Acronym / sponsor ID
- IRB-300017113
- Conditions
- Methamphetamine Use Disorder
- Keywords
- psilocybin, methamphetamine, HEAL Initiative, psychedelic-assisted therapy, substance use disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Peter HendricksUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2032 (estimated)
- Study completion
- 1 Feb 2032 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Single-site, phased UG3/UH3 randomized, quadruple-masked, parallel-group controlled trial (target N = 42). Participants are randomized 1:1 to a single administration of psilocybin at one of two dose levels, each delivered with a manualized platform of two preparation and two integration sessions. The specific doses are withheld in this registration during the conduct of the trial to preserve masking and reduce expectancy effects, and will be reported with results. The UG3 phase (n = 12) establishes feasibility and safety; the UH3 phase (n = 30) expands enrollment with longer follow-up. Support is provided by the HEAL Initiative (https://www.nih.gov/heal).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin, Dose A | Experimental | Drug: Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct)., Behavioral: Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct). |
| Psilocybin, Dose B | Experimental | Drug: Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct)., Behavioral: Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- A goal of complete abstinence on the Thoughts About Abstinence questionnaire
Key exclusion criteria (8 listed)
- 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)
- Personal history of any psychotic or bipolar I/II disorder, or a first- or second-degree relative with such
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct).The 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. | Drug | Psilocybin, Dose A, Psilocybin, Dose B |
| Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).Manualized CBT, adapted from Hendricks et al. (2026; https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2848757) | Behavioural | Psilocybin, Dose A, Psilocybin, Dose B |
Primary outcome
Abstinent Days
Time frame: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Percentage of days abstinent from methamphetamine (Timeline Followback, urine-confirmed); possible range is 0% to 100%, with higher scores reflecting more abstinence.
11 secondary outcomes
Complete Abstinence
Time frame: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Methamphetamine Use Disorder in Remission
Time frame: 30/90-day (UG3), 30/90/180-day (UH3)
Health-related Quality of Life
Time frame: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Self-perceived Quality of Life
Time frame: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Craving
Time frame: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Withdrawal
Time frame: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Severity of Dependence
Time frame: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).
Mystical-type Experience
Time frame: Day of dosing (≈7 hours)
Challenging Experience
Time frame: Day of dosing (≈7 hours)
Emotional Breakthrough
Time frame: Day of dosing (≈7 hours)
Psychological Insight
Time frame: Day of dosing (≈7 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data, metadata, and a data dictionary will be shared through an NIH-designated repository accessible via the HEAL Data Ecosystem, consistent with the study's Data Management and Sharing Plan and the HEAL Public Access and Data Sharing Policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter S Hendricks, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct). and Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions). in people with Methamphetamine Use Disorder, run by Peter Hendricks at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seher Premani, MPH (205-975-7721, spremani@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abstinent Days (time frame: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.