Research Studies

Research Studies

Wholeness

Since our beginning in 2010 we at Wholeness have been focused on innovation. The best method to innovate in healthcare involves blending clinical practice with cutting edge research findings. This linkage between practice and research has been critical to our continued leadership in the field of mental health. For example, our early publications on the value of CBD/cannabidiol in mental health triggered a growing line of clinical research that has continued to this day and validated our early studies.

Scott Shannon was one of the pioneers with MDMA-assisted psychotherapy forty years ago and coming full circle now, Wholeness served as a site for the Phase III landmark trials between 2017 and 2022. Besides MDMA, Wholeness has also participated in psychedelic research with LSD and 5-MeO-DMT.

Ketamine-assisted psychotherapy has been part of our clinical offerings since 2016 and we have remained central to the development of this rapidly growing professional specialty. Our grant driven work with first responders and front line health care personnel documents the value of this group-based intervention. It has been embraced as a fast and cost-effective alternative to psychiatric medication by local professionals eager to return to a full life.

We formed an aligned nonprofit called the Psychedelic Research and Training Institute (PRATI) (www.pratigroup.org) in 2019 that has been very successful and is now fully independent. Wholeness providers and those we trained make up much of the faculty for these sought-after trainings that typically sell out in 5-10 minutes to professionals from around the US.

We also innovate in other arenas outside psychedelics. As a leader in this field our publications cover significant terrain including non-medication approaches. In a collaborative study done with Colorado State University, Mary Rondeau, ND and our team demonstrated that a naturopathically informed holistic approach could effectively treat depression in young people. Steve Rondeau, ND has leveraged his deep experience with brain mapping and neurofeedback into multiple publications on the value of quantitative EEG (qEEG) in predicting treatment response and clinical risk.

We currently provide retreats in Costa Rica that combine ketamine and psilocybin-assisted therapy in a group format with other immersive holistic interventions. The results have been so remarkable in terms of personal transformation that we have decided to establish a Colorado base for this retreat work. We will gather data on an immersive and collaborative holistic model to publish. This how we move the current failing model of mental health treatment forward: Innovate, research, practice, lead. No other clinic in the world has a broader, more credible and more diverse pedigree for clinical innovation.

There is an ongoing psychedelic clinical research study evaluating safety and efficacy of intranasal study drug for patients with treatment resistant depression

The Wholeness Center is currently recruiting participants for a new study that is looking to investigate the psychedelic substance, 5-MeO Dimethyltryptamine (5-MeO-DMT), as a potential medicine for Treatment Resistant Depression (i.e. depression that has not responded to two or more medications in the current depressive episode).

5-MeO-DMT is a ‘psychedelic’ drug that occurs naturally in many plants and some animals and is one of several controlled substances currently being investigated for their potential therapeutic properties. This clinical trial will investigate the safety and efficacy of 5-MeO-DMT when given together with psychological support in people with Treatment Resistant Depression to determine whether it is useful to investigate further for this condition.

If you know anybody who might be interested in participating in the study, please direct them to this form to fill out to explore their potential eligibility.

Link to form

Additional Criteria Apply

If eligible, study participants will be expected to

  • abstain from illicit drugs for the duration of the trial
  • Attend all study visits and follow instructions from study doctor
To Qualify, Patients Need to be
  • 18-75 years of age
  • failed to respond to an adequate dose and duration of at least 2 medicines for depression
  • if currently taking antidepressants, willing and able to discontinue

Study related services are provided at no cost to you.

For more information, please contact:

Enrique J. Mercado

305- 707- 4672

enrique@wholenessresearch.com