Investigation of Cannabis for Chronic Pain and Palliative Care
Schlüsselwörter
Abstrakt
Beschreibung
The goal of this study is to perform a double-blind, placebo-controlled study to investigate the efficacy of cannabis, compared to placebo, in medically ill participants seeking relief symptoms such as pain, nausea, and vomiting. Participants who meet criteria for severe conditions will be referred from their clinicians . Cannabis that has a high concentration of cannabidiol, which is a cannabinoid that does not change perception or produce intoxication, and low in Δ-9-THC will be used. In this way, the hope is to maximize the benefit of cannabis, while lowering the possible side effects of cannabis in medically ill participants.
The overall goal of this study is to compare active high cannabidiol (CBD)/ low (−)-trans-Δ9- tetrahydrocannabinol (THC) cannabis vs placebo cannabis in patients with serious medical disorders. Participants will be referred from clinicians and will come to the laboratory daily (3-5 times weekly) for cannabis (15.76% CBD; 3.11% Δ-9-THC) vs placebo (0.0% CBD/ 0.01% Δ-9-THC). The cannabis will be vaporized or smoked as a cannabis cigarette. The participants can choose which option they prefer. The cross-over design will be used where participants receive 2 weeks of active cannabis vs two weeks of placebo in counterbalanced order, with participants blinded to the condition. The outcome measures primarily include measures of pain, with secondary measures of mood, nausea/appetite, quality of life, and the both the potentially positive and negative subjective effects of cannabis (e.g., high, mellow, anxious, paranoid).
Termine
| Zuletzt überprüft: | 01/31/2019 |
| Zuerst eingereicht: | 02/10/2016 |
| Geschätzte Einschreibung eingereicht: | 02/15/2016 |
| Zuerst veröffentlicht: | 02/16/2016 |
| Letztes eingereichtes Update: | 02/25/2019 |
| Letztes Update veröffentlicht: | 02/27/2019 |
| Tatsächliches Startdatum der Studie: | 11/30/2050 |
| Geschätztes primäres Abschlussdatum: | 11/30/2050 |
| Voraussichtliches Abschlussdatum der Studie: | 11/30/2050 |
Zustand oder Krankheit
Intervention / Behandlung
Drug: Smoked Cannabis High CBD/low THC
Drug: Smoked Placebo Cannabis Low CBD/low THC
Phase
Armgruppen
| Arm | Intervention / Behandlung |
|---|---|
| Active Comparator: Smoked Cannabis High CBD/low THC Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 Smoked Cannabis High CBD/low THC cigarettes (15.76% CBD; 3.11% THC) over the course of a 2-3 hour session. | Drug: Smoked Cannabis High CBD/low THC Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (15.76% CBD; 3.11% THC) over the course of a 2-3 hour session. |
| Placebo Comparator: Smoked Placebo Cannabis Low CBD/low THC Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (0.01% THC; 0.00% CBD) over the course of a 2-3 hour session. | Drug: Smoked Placebo Cannabis Low CBD/low THC Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (0.01% THC; 0.00% CBD) over the course of a 2-3 hour session. |
Zulassungskriterien
| Altersberechtigt für das Studium | 21 Years Zu 21 Years |
| Studienberechtigte Geschlechter | All |
| Akzeptiert gesunde Freiwillige | Ja |
| Kriterien | Inclusion Criteria: 1. One of the medical diagnoses (cancer, amyotrophic lateral sclerosis, Parkinson's disease, spinal cord injury, neuropathy, and phantom limb pain, thalamic pain, pain related to injury of nerve plexus/plexi, and neuropathic facial pain), with reports of pain (at least 3 on item 3 on the 9 item Brief Pain Inventory)that remains despite their current medical treatment. 2. Age 21-60 3. Able to give informed consent, and comply with study procedures 4. Experience inhaling substances. Exclusion Criteria: 1. Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidality, or psychosis, that could be exacerbated by the administration of cannabis 2. Meet criteria for major neurological disorder, such as mild cognitive impairment or neurodegenerative disorders (such as movement disorders, dementia), that could be exacerbated by the administration of cannabis. 3. Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant 4. Current (weekly) use of cannabis 5. Participants on supplemental oxygen 6. Participants with a substance use disorder involving marijuana or opioids. |
Ergebnis
Primäre Ergebnismaße
1. Change in pain ratings using the McGill Pain Questionnaire [4 weeks]
2. Change in sickness-related impairment using the Sickness Impact Profile [4 weeks]
3. changes in physical and emotional well being using the RAND-36 item medical outcomes survey, a health-related quality of life survey instrument [4 weeks]
4. Changes in symptoms of pain using the 9 item Brief Pain Inventory [4 weeks]
Sekundäre Ergebnismaße
1. Change in cognitive status using the Short Portable Mental Status Questionnaire (SPMSQ) [4 weeks]
2. Change in symptom prevalence, characteristics and degree of stress using the Memorial Symptom Assessment Scale (MSAS) [4 weeks]
3. Change in the psychological state and psychological well being using the Mental Health Inventory-5 (MHI-5) [4 weeks]
4. Changes in quality of life using the Multidimensional Index of Life Quality (MILQ) Questionnaire [4 weeks]
5. Changes in quality of life using the McGill Quality of Life Questionnaire [4 weeks]
6. Change in symptoms of pain, mood and appetite using the Edmonton Symptom Assessment System (ESAS) [4 weeks]
7. Memorial Symptom Assessment Scale (MSAS) [4 weeks]
8. Change in mood using the Hamilton Depression Rating Scale [4 weeks]
9. Change in mood Hamilton Anxiety Rating Scale [4 weeks]
10. Change in mood using the Montgomery-Asberg Depression Rating Scale [4 weeks]
11. Change in mood and quality of life using the Columbia Suicide Severity Rating Scale [4 weeks]
