Amphetamine-Related DisordersPhase 1/2NCT04982796
Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
A Phase 1/2 study testing Psilocybin and Treatment-as-usual in people with Amphetamine-Related Disorders, run by Portland VA Research Foundation, Inc at 1 site in United States.
Trial summary
This is a proof-of-concept randomized clinical trial of psilocybin-enhanced psychotherapy versus treatment-as-usual among individuals being treated for methamphetamine use disorder. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Amphetamine-Related Disorders
- What is being tested?
- Psilocybin and Treatment-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2022to 31 Dec 2026
- Phase
- Phase 1/2
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- United States military Veteran
- Moderate to severe methamphetamine use disorder using the DSM-V diagnostic criteria
- Desire to cease or reduce methamphetamine use
Who cannot join
- Have uncontrolled hypertension or clinically significant cardiovascular disease
- History of seizure disorder in adulthood
- CNS metastases or symptomatic central nervous system (CNS) infection
- Poorly controlled diabetes mellitus
- Taking certain medications that may interact with psilocybin
- History of any primary persistent psychotic disorder, including schizophrenia, schizoaffective disorder, bipolar disorder with psychosis, major depressive disorder with psychosis, or schizophreniform disorder
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- History of bipolar I disorder
- Current eating disorder with active purging
- History of hallucinogen use disorder
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Portland VA Health Care System
Vancouver, Washington, 98661
About this study
This is a proof-of-concept randomized clinical trial of psilocybin-enhanced psychotherapy versus treatment-as-usual among individuals being treated for methamphetamine use disorder.
Read the detailed description
The trial will take place with individuals admitted to a residential rehabilitation treatment program. The treatment protocol will consist of 4 preparatory therapy visits, 2 psilocybin sessions (25-30mg), and 8 total integration therapy visits. Primary aims assess acceptability, feasibility, and safety with a primary endpoint at the conclusion of the study intervention. An additional aim assesses preliminary efficacy for methamphetamine use disorder and overall functioning at follow-up assessments 60 and 180 days after discharge from the residential treatment program.
- Conditions
- Amphetamine-Related Disorders
- Being tested
- Psilocybin, Treatment-as-usual
- Keywords
- methamphetamine, stimulant, psilocybin, psychedelic, psychotherapy
- Medical subject headings
- Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
See description of psilocybin-enhanced psychotherapy arm.
Treatment-as-usualBehavioural
See description of treatment-as-usual arm.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin-enhanced psychotherapy | Experimental | Psilocybin will be administered twice (25mg \& 30mg two weeks apart) in addition to a 6-week psychotherapy protocol while admitted to a residential rehabilitation treatment program. Receives: Drug: Psilocybin; Behavioral: Treatment-as-usual |
| Treatment-as-Usual | Other | Treatment-as-usual while admitted to a residential rehabilitation treatment program. Receives: Behavioral: Treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
We will use a 7-point Likert scale to measure each participant's perceived benefit and perceived harm of the intervention.
Measured: End of 6-week intervention; approximately 42 days
Proportion of patients who complete the intervention and follow-up
We will observe the proportion of patients who complete the intervention and follow-up to determine feasibility.
Measured: End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days
Secondary outcomes (8)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Number of Participants Who Experienced Treatment-related Adverse Events as defined by the FDA (21 Code of Federal Regulations [CFR] 312.32(a)). Adverse events assessed at every study visit by clinical observation and patient interview.
Measured: 180 day post-discharge follow-up; approximately 222 days post-enrollment
Methamphetamine Use, self-report
Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks.
Measured: 60 days post-discharge follow-up; approximately 102 days post-enrollment
Methamphetamine Use, self-report
Using the Timeline Follow-Back procedure, average number of days per week used methamphetamine over the past four weeks.
Measured: 180 days post-discharge follow-up; approximately 222 days post-enrollment
Methamphetamine Use, urine
Urine drug screen
Measured: 60 days post-discharge follow-up; approximately 102 days post-enrollment
Methamphetamine Use, urine
Urine drug screen
Measured: 180 days post-discharge follow-up; approximately 222 days post-enrollment
Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention
Sheehan Disability Scale total score, a measure of clinician-rated functional impairment. SDS scores range from 0 (not impaired) to 30 (highly impaired).
Measured: approximately 42 days post-enrollment
Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up
Sheehan Disability Scale total score, a measure of clinician-rated functional impairment
Measured: approximately 102 days post-enrollment
Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up
Sheehan Disability Scale total score, a measure of clinician-rated functional impairment
Measured: approximately 222 days post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start7 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amphetamine-Related DisordersStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portland VA Research Foundation, Inc
- Sponsor type
- University, hospital or other
- Collaborators
- Steven & Alexandra Cohen Foundation
- Responsible party
- Sponsor
- Investigators
- Chris Stauffer, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04982796
- Sponsor's protocol ID
- 01
- Status last verified
- Apr 2026
- First submitted
- 19 Jul 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT04982796
- Acronym / sponsor ID
- 01
- Conditions
- Amphetamine-Related Disorders
- Keywords
- methamphetamine, stimulant, psilocybin, psychedelic, psychotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Portland VA Research Foundation, IncUniversity, hospital or other
- Collaborators
- Steven & Alexandra Cohen Foundation
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jul 2021 (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 is a proof-of-concept randomized clinical trial of psilocybin-enhanced psychotherapy versus treatment-as-usual among individuals being treated for methamphetamine use disorder.
Detailed description
The trial will take place with individuals admitted to a residential rehabilitation treatment program. The treatment protocol will consist of 4 preparatory therapy visits, 2 psilocybin sessions (25-30mg), and 8 total integration therapy visits. Primary aims assess acceptability, feasibility, and safety with a primary endpoint at the conclusion of the study intervention. An additional aim assesses preliminary efficacy for methamphetamine use disorder and overall functioning at follow-up assessments 60 and 180 days after discharge from the residential treatment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin-enhanced psychotherapy | Experimental | Drug: Psilocybin, Behavioral: Treatment-as-usualPsilocybin will be administered twice (25mg \& 30mg two weeks apart) in addition to a 6-week psychotherapy protocol while admitted to a residential rehabilitation treatment program. |
| Treatment-as-Usual | Other | Behavioral: Treatment-as-usualTreatment-as-usual while admitted to a residential rehabilitation treatment program. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- United States military Veteran
- Moderate to severe methamphetamine use disorder using the DSM-V diagnostic criteria
- Desire to cease or reduce methamphetamine use
Key exclusion criteria (10 listed)
- Have uncontrolled hypertension or clinically significant cardiovascular disease
- History of seizure disorder in adulthood
- CNS metastases or symptomatic central nervous system (CNS) infection
- Poorly controlled diabetes mellitus
- Taking certain medications that may interact with psilocybin
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 |
|---|---|---|
| PsilocybinSee description of psilocybin-enhanced psychotherapy arm. | Drug | Psilocybin-enhanced psychotherapy |
| Treatment-as-usualSee description of treatment-as-usual arm. | Behavioural | Psilocybin-enhanced psychotherapy, Treatment-as-Usual |
Primary outcome
Acceptability
Time frame: End of 6-week intervention; approximately 42 days
We will use a 7-point Likert scale to measure each participant's perceived benefit and perceived harm of the intervention.
Proportion of patients who complete the intervention and follow-up
Time frame: End of 6-week intervention to 180 days post-discharge follow-up; approximately 180 days
We will observe the proportion of patients who complete the intervention and follow-up to determine feasibility.
8 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 180 day post-discharge follow-up; approximately 222 days post-enrollment
Methamphetamine Use, self-report
Time frame: 60 days post-discharge follow-up; approximately 102 days post-enrollment
Methamphetamine Use, self-report
Time frame: 180 days post-discharge follow-up; approximately 222 days post-enrollment
Methamphetamine Use, urine
Time frame: 60 days post-discharge follow-up; approximately 102 days post-enrollment
Methamphetamine Use, urine
Time frame: 180 days post-discharge follow-up; approximately 222 days post-enrollment
Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention
Time frame: approximately 42 days post-enrollment
Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up
Time frame: approximately 102 days post-enrollment
Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up
Time frame: approximately 222 days post-enrollment
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 22 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Chris Stauffer, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psilocybin and Treatment-as-usual in people with Amphetamine-Related Disorders, run by Portland VA Research Foundation, Inc 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 3 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: End of 6-week intervention; approximately 42 days). The study lists 2 primary outcomes in all. 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 22 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.