Is NCT06526208 recruiting in Phoenix, AZ?

Yes, NCT06526208 is currently recruiting participants at its Phoenix, AZ location. This autism spectrum disorder clinical trial is actively enrolling qualified participants.

How do I join the autism spectrum disorder clinical trial in Phoenix?

To join this clinical trial in Phoenix, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Phoenix clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Autism Spectrum Disorder Clinical Trial in Phoenix, AZ

About This Autism Spectrum Disorder Study in Phoenix

The goal of this clinical trial is to learn if drug ABC works to treat severe asthma in adults. It will also learn about the safety of drug ABC. The main questions it aims to answer are: Will a marijuana-based drug help anxiety in autistic adults? Anxiety can make socializing and working more difficult for people. Researchers will compare a marijuana based drug (that is mostly CBD with a small amount of THC) to a placebo (a look-alike substance that contains no drug) to see if the drug makes symptoms of anxiety better. Participants will take the drug (or a placebo) every day for 8 weeks and keep a diary to record the time they took the drug, and their feelings each day. The drug is taken orally in drops once or twice a day. The study staff will speak to the participants weekly either over the phone or in the clinic. Clinic visits once every 2 weeks for checkups and tests. The researchers will make sure participants are healthy and see if there are any changes in anxiety.

Sponsor: Southwest Autism Research & Resource Center

Who Can Participate

Inclusion Criteria

Male or female age 18 to 45 years old with an autism diagnosis.

Participant is ≥ 100 lbs.

Participant or a legally authorized representative provides informed consent/assent for participation in the trial.

Participant/caregiver is willing and able to comply with all study procedures.

Participant meets ADOS-2 criteria for Autism or Autism Spectrum

Participant meets DSM-5 criteria for ASD.

Participant has a minimum CGI-S (Anxiety) score ≥ 5 based on anxiety related social functional impairment.

Participant has a FSIQ ≥ 65 at screening measured with the WASI- II, or within 1 year of screening with a comparable assessment.

Participant must have a negative pregnancy test (urine and serum) at Screening, and a negative urine test at Baseline, Active Phase Visits, and EoS visits, see Table 1. Schedule of Activities.

Sexually active participants agree to use two methods of effective birth control, as described in Appendix B: Contraceptive and Barrier Guidance during the study intervention period and for at least 14 days after the Study Termination visit.

Participant must be stable on any pre-study medications and/or psychotherapy for 6-weeks prior to study enrollment, agree to inform prescribing clinician(s) about participation in the study, and agree to maintain medication or psychotherapy treatment regimen during the study.

Participant must be able to ingest MB-IMP (or placebo) and be willing to commit to medication dosing and completing the dosing diary.

Participant/caregiver agrees to keep all study medication provided by site staff securely stored at home and not to share/distribute study medication to any other individual.

Participant agrees not to participate in any other interventional clinical trials during the study period.

Participant agrees to inform the investigators within 48- hours of any side-effects, medical conditions, and procedures.

Participant agrees to abstain from alcohol use during the study.

Exclusion Criteria

Participant weighs \&amp;lt; 100 lbs.

Participant is sexually active and does not practice two effective forms of birth control.

Participant is pregnant, lactating, or planning pregnancy during the study period or within 12 weeks thereafter.

Participant has a current or historical psychotic features/disorder assessed via the Mini-International Neuropsychiatric Interview (MINI).

Participant has a current or historical DSM-5 diagnosis of dissociative identity disorder, positive family history (first-degree relative) of psychotic disorder or bipolar disorder type 1.

At high risk of suicide or suicide attempts.

Individuals presenting current serious suicide risk, as determined through psychiatric interview, responses to the Columbia Suicide Severity Rating Scale (C-SSRS), and/or clinical judgment of the investigator.

History of suicide attempts within 12 months prior to study enrollment.

Participant has a current substance use disorder within the 12 months prior to enrollment as determined by the MINI Kid56.

Participant's urine drug screen is positive for opiates, methamphetamine, cocaine, THC, and amphetamines (unless prescribed). Participants with positive THC urine analysis tests are excluded from the study but will be allowed to rescreen (maximum twice) after a 1-month cessation of cannabis use.

Participant has a history of arrhythmia, other than occasional premature atrial contractions (PACs) and premature ventricular contractions (PVCs) without ischemic heart disease, within 12 months of screening.

Participant with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia, or any other arrhythmia associated with a bypass tract, may be enrolled only if they have been successfully treated with ablation and have not had a recurrent arrhythmia for at least one year off all antiarrhythmic drugs or are under adequate and stable pharmacologic treatment for atrial fibrillation for at least a year, as confirmed by a cardiologist.

Participant has a current diagnosis or evidence of significant or uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, renal, immunocompromising, or neurological disease according to PI's discretion.

Evidence of existing hepatocellular injury defined as alanine transaminase (ALT) and aspertate aminotranferase (AST) elevations of greater than 3 times upper limit normal (ULN) and bilirubin elevation of greater than 2 times ULN.

The PI or medical monitor deems the participant inappropriate for the study for any reason.

Any known allergies/sensitivities to cannabis (in the opinion of the investigator).

Not able to attend required face-to-face visits or those who plan to move out of the area within the treatment period.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Phoenix?

Yes, this clinical trial (NCT06526208) has an active research site in Phoenix, AZ that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Autism Spectrum Disorder Treatment Options in Phoenix, AZ

If you're searching for autism spectrum disorder treatment options in Phoenix, AZ, this clinical trial (NCT06526208) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Phoenix research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced autism spectrum disorder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all autism spectrum disorder clinical trials near you to find additional studies recruiting in your area.

Autism Spectrum Disorder Clinical Trial in Phoenix, AZ

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