Illness TerminalPhase 2KRF-EOLNCT05214417
Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy
A Phase 2 study testing Ketamine Injectable Solution in people with Illness Terminal, run by The Ketamine Research Foundation.
Trial summary
The Conscious Dying/Conscious Living study will investigate the effect of KAP (ketamine-assisted psychotherapy) on individuals with terminal illness at five separate geographic locations. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Illness Terminal
- What is being tested?
- Ketamine Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 31 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Decision making capacity including conscious awareness and sufficient memory capacity.
- Ability to provide informed consent.
- Understanding of English language and ability to converse.
- 12 months or less life expectancy by prognosis.
- Age 18-85.
- Able to identify one or two Caregiver/Support Person(s) (relative, spouse, close friend, or other caregiver) who willing provide the following functions: 1) to drive the participant home on medication visits (if applicable), 2) to be reached by Clinical Investigator(s) in the event of a subject becoming suicidal or ill, and 3) to provide collateral information as needed. See Appendix D for Consent form.
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- Have significant anxiety about impending death with a STAI Trait score of 45 or greater.
- If the individual has a documented history of anxiety disorder, the patient and investigator are in agreement that the individual's present anxiety is primarily resultant from or exacerbated by their illness and approaching death.
- May continue but not change psychiatric medications during the course of the study.
- May continue but not change therapists during the course of the study.
- Willing to refrain from using stimulants, anxiolytics, and PI designated medications during the day of the study sessions.
- Willing to refrain from using alcohol and marijuana for 24 hours before-- and the day of study sessions.
- Agrees to refrain from the use of any psychoactive drug during the course of the study., this referring to "Any drug that affects the nervous system leading to any or all of the following: Alterations in mood, awareness, thoughts, feelings, perception, cognition, or behavior.
- If necessary, are willing to be contacted via telephone on a daily basis by one of the therapists for a week after each experimental session
Who cannot join
- Clinical evidence of significant dementia or other cognitive impairment.
- Hypertension: Defined as Systolic greater than 145 or Diastolic greater than 95.
- History in intracranial bleeds or stroke.
- History of seizures.
- Known hypersensitivity to ketamine
- Class 2 or above heart disease.
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- Below age 18 or above age 85.
- Subjects who are assessed to be at high risk of suicidal ideation or behavior.
- Have a history (or current diagnosis) of any of the following psychiatric disorders: a primary psychotic disorder, bipolar affective disorder type 1, dissociative identity disorder, an eating disorder (i.e., anorexia or bulimia), or a personality disorder that, in the opinion of the investigator, would interfere with the patient's participation in the study.
- IF receiving medication that may cause blunting of responses, and diminished affect such as antipsychotics, exclusion will be as per the evaluation of the PI and staff.
- Have evidence or history of significant (controlled or uncontrolled) cerebrovascular or cardiovascular disease, or any other medical disorder judged by the Principal Investigator(s) to significantly increase the risk of ketamine administration. Baseline Heart rate 110BPM or less; Greater than 50 BPM.
- Renal failure and dialysis.
- If on oxygen support, receiving no more than 4 liters
- Are experiencing cognitive and/or affective deficits as a result of ongoing chemotherapy that, in the opinion of the investigator, would interfere with the subject's ability to participate in the study.
- Have evidence or history of liver disease that would affect metabolism of ketamine. Transaminases do not exceed 3 times normal range
- Meet DSM-V criteria for substance abuse or dependence for any substance in the past sixty days except caffeine or nicotine-with the exception of opiates used prn for pain.
- Pregnant and Lactating Women
- Have any current problem, which in the opinion of the Principal Investigator(s) might interfere with participation in the study
- Are not able to give adequate informed consent
- Patients referred to our study who have by history electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia), congestive heart failure, bradyarrhythmias, or patients taking concomitant medications that prolong the QT interval will be excluded as ondansetron may need to be used.
- Patients who are allergic to ondansetron will be excluded
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy (KAP) for Patients at End of Life-A Pilot Study for Palliative and Hospice Care
The Conscious Dying/Conscious Living study will investigate the effect of KAP (ketamine-assisted psychotherapy) on individuals with terminal illness at five separate geographic locations. Two separate IM ketamine sessions will be administered to 18 subjects at each site, with psychotherapeutic support, including preparatory and integrative sessions. Assessments will be administered throughout the course of the protocol, which will take 4-6 weeks to complete, and the primary outcome measures are changes in the STAI (State-trait Anxiety Inventory, trait assessment only) and the DADDS (Death and Dying Distress Scale) from baseline at the beginning of the study to the conclusion of the treatment period. A six-subject naturalistic comparator group at each site will complete the same assessments without intervention, and then will be offered an optional crossover KAP treatment.
- Conditions
- Illness Terminal
- Being tested
- Ketamine Injectable Solution, Naturalistic Control
- Keywords
- ketamine, ketamine assisted psychotherapy, palliative care, hospice, death and dying, conscious dying, psychedelic psychotherapy, psychedelics, end of life, life threatening illnesses
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine Injectable SolutionDrug
2 IM ketamine sessions with psychotherapy, spaced 9-15 days apart
Naturalistic ControlOther
Continuation of pre-existing conventional treatment
| Study group | Role | What they receive |
|---|---|---|
| KAP (Ketamine-assisted Psychotherapy) Recipients | Experimental | Two separate IM ketamine injection sessions, with possible multiple doses administered at each session not to exceed 100 mg IM ketamine total for the session. Receives: Drug: Ketamine Injectable Solution |
| Naturalistic Comparator | Other | Pre-existing conventional treatment will continue for this group during the study period. Receives: Other: Naturalistic Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory (STAI) Form Y-2 (Trait Only)
Change in STAI (trait only) from baseline to conclusion of treatment (minimum 20/maximum 80, higher scores indicate increased anxiety and a worse outcome)
Measured: 18-32 days
Death and Dying Distress Scale (DADDS)
Change in DADDS from baseline to conclusion of treatment (minimum 0/maximum 75, higher scores indicate increased death anxiety and a worse outcome)
Measured: 18-32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 May 2022 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (73)Papers the sponsor has linked to this study.
- Other trials for Illness TerminalStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Ketamine Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philip E Wolfson, MD, Principal investigator, Ketamine Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214417
- Sponsor's protocol ID
- KRF-EOL
- Acronym
- KRF-EOL
- Status last verified
- Feb 2022
- First submitted
- 17 Jan 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andrykowski MA, Cordova MJ, Studts JL, Miller TW. Posttraumatic stress disorder after treatment for breast cancer: prevalence of diagnosis and use of the PTSD Checklist-Civilian Version (PCL-C) as a screening instrument. J Consult Clin Psychol. 1998 Jun;66(3):586-90. doi: 10.1037//0022-006x.66.3.586.
PubMed 9642900Angrist B, d'Hollosy M, Sanfilipo M, Satriano J, Diamond G, Simberkoff M, Weinreb H. Central nervous system stimulants as symptomatic treatments for AIDS-related neuropsychiatric impairment. J Clin Psychopharmacol. 1992 Aug;12(4):268-72.
PubMed 1527230Arrieta O, Angulo LP, Nunez-Valencia C, Dorantes-Gallareta Y, Macedo EO, Martinez-Lopez D, Alvarado S, Corona-Cruz JF, Onate-Ocana LF. Association of depression and anxiety on quality of life, treatment adherence, and prognosis in patients with advanced non-small cell lung cancer. Ann Surg Oncol. 2013 Jun;20(6):1941-8. doi: 10.1245/s10434-012-2793-5. Epub 2012 Dec 22.
PubMed 23263699Barth J, Schumacher M, Herrmann-Lingen C. Depression as a risk factor for mortality in patients with coronary heart disease: a meta-analysis. Psychosom Med. 2004 Nov-Dec;66(6):802-13. doi: 10.1097/01.psy.0000146332.53619.b2.
PubMed 15564343Boston P, Bruce A, Schreiber R. Existential suffering in the palliative care setting: an integrated literature review. J Pain Symptom Manage. 2011 Mar;41(3):604-18. doi: 10.1016/j.jpainsymman.2010.05.010. Epub 2010 Dec 8.
PubMed 21145202Breitbart W, Rosenfeld B, Pessin H, Applebaum A, Kulikowski J, Lichtenthal WG. Meaning-centered group psychotherapy: an effective intervention for improving psychological well-being in patients with advanced cancer. J Clin Oncol. 2015 Mar 1;33(7):749-54. doi: 10.1200/JCO.2014.57.2198. Epub 2015 Feb 2.
PubMed 25646186Breen LJ, O'Connor M, Hewitt LY, Lobb EA. The "specter" of cancer: exploring secondary trauma for health professionals providing cancer support and counseling. Psychol Serv. 2014 Feb;11(1):60-7. doi: 10.1037/a0034451. Epub 2013 Sep 30.
PubMed 24079353Brown KW, Levy AR, Rosberger Z, Edgar L. Psychological distress and cancer survival: a follow-up 10 years after diagnosis. Psychosom Med. 2003 Jul-Aug;65(4):636-43. doi: 10.1097/01.psy.0000077503.96903.a6.
PubMed 12883115Bruera E, Driver L, Barnes EA, Willey J, Shen L, Palmer JL, Escalante C. Patient-controlled methylphenidate for the management of fatigue in patients with advanced cancer: a preliminary report. J Clin Oncol. 2003 Dec 1;21(23):4439-43. doi: 10.1200/JCO.2003.06.156.
PubMed 14645434Brundtland GH. From the World Health Organization. Mental health: new understanding, new hope. JAMA. 2001 Nov 21;286(19):2391. doi: 10.1001/jama.286.19.2391. No abstract available.
PubMed 11712923Busolo D, Woodgate R. Palliative care experiences of adult cancer patients from ethnocultural groups: a qualitative systematic review protocol. JBI Database System Rev Implement Rep. 2015 Jan;13(1):99-111. doi: 10.11124/jbisrir-2015-1809.
PubMed 26447011Carey LB, Hodgson TJ, Krikheli L, Soh RY, Armour AR, Singh TK, Impiombato CG. Moral Injury, Spiritual Care and the Role of Chaplains: An Exploratory Scoping Review of Literature and Resources. J Relig Health. 2016 Aug;55(4):1218-45. doi: 10.1007/s10943-016-0231-x.
PubMed 27094705Carney RM, Blumenthal JA, Catellier D, Freedland KE, Berkman LF, Watkins LL, Czajkowski SM, Hayano J, Jaffe AS. Depression as a risk factor for mortality after acute myocardial infarction. Am J Cardiol. 2003 Dec 1;92(11):1277-81. doi: 10.1016/j.amjcard.2003.08.007.
PubMed 14636903Carney RM, Freedland KE. Depression, mortality, and medical morbidity in patients with coronary heart disease. Biol Psychiatry. 2003 Aug 1;54(3):241-7. doi: 10.1016/s0006-3223(03)00111-2.
PubMed 12893100Carr DB, Goudas LC, Denman WT, Brookoff D, Staats PS, Brennen L, Green G, Albin R, Hamilton D, Rogers MC, Firestone L, Lavin PT, Mermelstein F. Safety and efficacy of intranasal ketamine for the treatment of breakthrough pain in patients with chronic pain: a randomized, double-blind, placebo-controlled, crossover study. Pain. 2004 Mar;108(1-2):17-27. doi: 10.1016/j.pain.2003.07.001.
PubMed 15109503
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conscious Dying/Conscious Living: Ketamine-Assisted Psychotherapy (KAP) for Patients at End of Life-A Pilot Study for Palliative and Hospice Care
- ClinicalTrials.gov ID
- NCT05214417
- Acronym / sponsor ID
- KRF-EOL / KRF-EOL
- Conditions
- Illness Terminal
- Keywords
- ketamine, ketamine assisted psychotherapy, palliative care, hospice, death and dying, conscious dying, psychedelic psychotherapy, psychedelics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Ketamine Research FoundationUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 28 Jan 2022 (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.
The Conscious Dying/Conscious Living study will investigate the effect of KAP (ketamine-assisted psychotherapy) on individuals with terminal illness at five separate geographic locations. Two separate IM ketamine sessions will be administered to 18 subjects at each site, with psychotherapeutic support, including preparatory and integrative sessions. Assessments will be administered throughout the course of the protocol, which will take 4-6 weeks to complete, and the primary outcome measures are changes in the STAI (State-trait Anxiety Inventory, trait assessment only) and the DADDS (Death and Dying Distress Scale) from baseline at the beginning of the study to the conclusion of the treatment period. A six-subject naturalistic comparator group at each site will complete the same assessments without intervention, and then will be offered an optional crossover KAP treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KAP (Ketamine-assisted Psychotherapy) Recipients | Experimental | Drug: Ketamine Injectable SolutionTwo separate IM ketamine injection sessions, with possible multiple doses administered at each session not to exceed 100 mg IM ketamine total for the session. |
| Naturalistic Comparator | Other | Other: Naturalistic ControlPre-existing conventional treatment will continue for this group during the study period. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Decision making capacity including conscious awareness and sufficient memory capacity.
- Ability to provide informed consent.
- Understanding of English language and ability to converse.
- 12 months or less life expectancy by prognosis.
- Age 18-85.
Key exclusion criteria (21 listed)
- Clinical evidence of significant dementia or other cognitive impairment.
- Hypertension: Defined as Systolic greater than 145 or Diastolic greater than 95.
- History in intracranial bleeds or stroke.
- History of seizures.
- Known hypersensitivity to ketamine
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 |
|---|---|---|
| Ketamine Injectable Solution2 IM ketamine sessions with psychotherapy, spaced 9-15 days apart | Drug | KAP (Ketamine-assisted Psychotherapy) Recipients |
| Naturalistic ControlContinuation of pre-existing conventional treatment | Other | Naturalistic Comparator |
Primary outcome
State-Trait Anxiety Inventory (STAI) Form Y-2 (Trait Only)
Time frame: 18-32 days
Change in STAI (trait only) from baseline to conclusion of treatment (minimum 20/maximum 80, higher scores indicate increased anxiety and a worse outcome)
Death and Dying Distress Scale (DADDS)
Time frame: 18-32 days
Change in DADDS from baseline to conclusion of treatment (minimum 0/maximum 75, higher scores indicate increased death anxiety and a worse outcome)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Background: PubMed 9642900Andrykowski MA, Cordova MJ, Studts JL, Miller TW. Posttraumatic stress disorder after treatment for breast cancer: prevalence of diagnosis and use of the PTSD Checklist-Civilian Version (PCL-C) as a screening instrument. J Consult Clin Psychol. 1998 Jun;66(3):586-90. doi: 10.1037//0022-006x.66.3.586.
- Background: PubMed 1527230Angrist B, d'Hollosy M, Sanfilipo M, Satriano J, Diamond G, Simberkoff M, Weinreb H. Central nervous system stimulants as symptomatic treatments for AIDS-related neuropsychiatric impairment. J Clin Psychopharmacol. 1992 Aug;12(4):268-72.
- Background: PubMed 23263699Arrieta O, Angulo LP, Nunez-Valencia C, Dorantes-Gallareta Y, Macedo EO, Martinez-Lopez D, Alvarado S, Corona-Cruz JF, Onate-Ocana LF. Association of depression and anxiety on quality of life, treatment adherence, and prognosis in patients with advanced non-small cell lung cancer. Ann Surg Oncol. 2013 Jun;20(6):1941-8. doi: 10.1245/s10434-012-2793-5. Epub 2012 Dec 22.
- Background: PubMed 15564343Barth J, Schumacher M, Herrmann-Lingen C. Depression as a risk factor for mortality in patients with coronary heart disease: a meta-analysis. Psychosom Med. 2004 Nov-Dec;66(6):802-13. doi: 10.1097/01.psy.0000146332.53619.b2.
- Background: PubMed 21145202Boston P, Bruce A, Schreiber R. Existential suffering in the palliative care setting: an integrated literature review. J Pain Symptom Manage. 2011 Mar;41(3):604-18. doi: 10.1016/j.jpainsymman.2010.05.010. Epub 2010 Dec 8.
- Background: PubMed 25646186Breitbart W, Rosenfeld B, Pessin H, Applebaum A, Kulikowski J, Lichtenthal WG. Meaning-centered group psychotherapy: an effective intervention for improving psychological well-being in patients with advanced cancer. J Clin Oncol. 2015 Mar 1;33(7):749-54. doi: 10.1200/JCO.2014.57.2198. Epub 2015 Feb 2.
- Background: PubMed 24079353Breen LJ, O'Connor M, Hewitt LY, Lobb EA. The "specter" of cancer: exploring secondary trauma for health professionals providing cancer support and counseling. Psychol Serv. 2014 Feb;11(1):60-7. doi: 10.1037/a0034451. Epub 2013 Sep 30.
- Background: PubMed 12883115Brown KW, Levy AR, Rosberger Z, Edgar L. Psychological distress and cancer survival: a follow-up 10 years after diagnosis. Psychosom Med. 2003 Jul-Aug;65(4):636-43. doi: 10.1097/01.psy.0000077503.96903.a6.
- Background: PubMed 14645434Bruera E, Driver L, Barnes EA, Willey J, Shen L, Palmer JL, Escalante C. Patient-controlled methylphenidate for the management of fatigue in patients with advanced cancer: a preliminary report. J Clin Oncol. 2003 Dec 1;21(23):4439-43. doi: 10.1200/JCO.2003.06.156.
- Background: PubMed 11712923Brundtland GH. From the World Health Organization. Mental health: new understanding, new hope. JAMA. 2001 Nov 21;286(19):2391. doi: 10.1001/jama.286.19.2391. No abstract available.
- Background: PubMed 26447011Busolo D, Woodgate R. Palliative care experiences of adult cancer patients from ethnocultural groups: a qualitative systematic review protocol. JBI Database System Rev Implement Rep. 2015 Jan;13(1):99-111. doi: 10.11124/jbisrir-2015-1809.
- Background: PubMed 27094705Carey LB, Hodgson TJ, Krikheli L, Soh RY, Armour AR, Singh TK, Impiombato CG. Moral Injury, Spiritual Care and the Role of Chaplains: An Exploratory Scoping Review of Literature and Resources. J Relig Health. 2016 Aug;55(4):1218-45. doi: 10.1007/s10943-016-0231-x.
- Use of the Classic Hallucinogen Psilocybin for Treatment of Existential Distress Associated with CancerLink provided by the sponsor.
- Ketamine: Dreams and RealitiesLink provided by the sponsor.
- 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.
Philip E Wolfson, MD principal investigator
Ketamine Research Foundation
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine Injectable Solution in people with Illness Terminal, run by The Ketamine Research Foundation.
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 14 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip E Wolfson, MD (415-550-1700, ketamine.research@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-Trait Anxiety Inventory (STAI) Form Y-2 (Trait Only) (time frame: 18-32 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?
On the ClinicalTrials.gov record for NCT05214417, which also lists 73 linked publications.
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 25 Feb 2022.