Die Wirkung von oral und rektal verabreichtem Delta-9-Tetrahydrocannabinol auf Spastizität: eine Pilotstudie mit 2 Patienten

The effect of orally and rectally administered delta 9-tetrahydrocannabinol on spasticity: a pilot study with 2 patients

Studie

Teilnehmer:

2

Darreichungsform:

Kapseln, Zäpfchen

Applikation:

Oral, Rektal

Autoren:

Brenneisen R, Egli A, Elsohly MA, Henn V, Spiess Y

Abstract

Multiple doses of delta 9-tetrahydrocannabinol (THC) capsules (Marinol) and THC hemisuccinate suppositories were administered in 24-hour intervals to 2 patients with organically caused spasticity. After oral doses of 10-15 mg THC, peak plasma levels from 2.1 to 16.9 ng/ml THC and 74.5 to 244.0 ng/ml 11-nor-9-carboxy-delta 9-tetrahydrocannabinol (THC-COOH, major THC metabolite) were measured by GC/MS within 1-8 h and 2-8 h, respectively. After rectal doses of 2.5-5 mg THC, peak plasma levels from 1.1 to 4.1 ng/ml THC and 6.1 to 42.0 ng/ml THC-COOH were measured within 2-8 h and 1-8 h, respectively. The bioavailability resulting from the oral formulation was 45-53% relative to the rectal route of administration, due to a lower absorption and higher first-pass metabolism. The effect of THC on spasticity, rigidity, and pain was estimated by objective neurological tests (Ashworth scale, walking ability) and patient self-rating protocols. Oral and rectal THC reduced at a progressive stage of illness the spasticity, rigidity, and pain, resulting in improved active and passive mobility. The relative effectiveness of the oral vs. the rectal formulation was 25-50%. Physiological and psychological parameters were used to monitor psychotropic and somatic side-effects of THC. No differences in the concentration ability, mood, and function of the cardiovascular system could be observed after administration of THC.

 

Sicherheit, Verträglichkeit und Wirksamkeit von oral verabreichten Cannabinoiden bei MS

Englischer Titel

Review/Studie

Teilnehmer:

16

Darreichungsform:

x

Applikation:

Oral

Autoren:

Killestein J, Hoogervorst EL, Reif M, Kalkers NF, Van Loenen AC, Staats PG, Gorter RW, Uitdehaag BM, Polman CH

Fundstelle:

https://pubmed.ncbi.nlm.nih.gov/12011290/

Abstract

The authors conducted a randomized, double-blind, placebo-controlled, twofold crossover study in 16 patients with MS who presented with severe spasticity to investigate safety, tolerability, and efficacy of oral Delta(9)-Tetrahydrocannabinol (THC) and Cannabis sativa plant extract. Both drugs were safe, but adverse events were more common with plant-extract treatment. Compared with placebo, neither THC nor plant-extract treatment reduced spasticity. Both THC and plant-extract treatment worsened the participant’s global impression.

 

TEST

Review

Teilnehmenranzahl:
Darreichungsform:
Applikation:
Autoren:
Fundstelle:

Platzhalter

Platzhalter

Platzhalter

Platzhalter

Platzhalter

Abstract

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Wirkung von Dronabinol auf den Ernährungszustand bei HIV-Infektionen

Effect of dronabinol on nutritional status in HIV infection

Studie

Teilnehmer:

12

Darreichungsform:

Tropfen (Öl)

Applikation:

Oral

Autoren:

Struwe M, Kaempfer SH, Geiger CJ, Pavia AT, Plasse TF, Shepard KV, Ries K, Evans TG

Abstract

Objective: To examine the effect of dronabinol (delta-9-tetrahydrocannabinol) on appetite and nutritional status in patients with symptomatic HIV infection and weight loss.

Design: Double-blind, randomized, placebo-controlled, crossover trial with two five-week treatment periods separated by a two-week washout period. Patients received dronabinol 5 mg twice daily before meals or placebo.

Setting: A university-based HIV/AIDS clinic and a large infectious disease private practice largely devoted to care of patients with HIV.

Participants: Twelve HIV-infected patients who had had at least a 2.25-kg weight loss participated in the study. Five patients completed the protocol, and seven withdrew (two because of drug intolerance, two because of disease progression, two because of noncompliance, and one because of experimental antiretroviral therapy).

Main outcome measures: Main outcome measures included caloric intake, weight, percent body fat, serum prealbumin, and symptom distress.

Results: During dronabinol treatment, subjects experienced increased percent body fat (one percent, p = 0.04); decreased symptom distress (p = 0.04); and trends toward weight gain (0.5 kg, p = 0.13), increased prealbumin (29.0 mg/L, p = 0.11), and improved appetite score (p = 0.14).

Conclusions: In a selected group of HIV-infected patients with weight loss, short-term treatment with dronabinol may result in improvement in nutritional status and symptom distress.

Cannabinoide zur Kontrolle von chemotherapiebedingter Übelkeit und Erbrechen: quantitativer systematischer Überblick

Cannabinoids for control of chemotherapy induced nausea and vomiting: quantitative systematic review

Review

Teilnehmer:

1366

Darreichungsform:

Tropfen, Spritze, Kapsel

Applikation:

Oral, intramuskulär

Autoren:

Tramèr MR, Carroll D, Campbell FA, Reynolds DJ, Moore RA, McQuay HJ

Abstract
Objective: To quantify the antiemetic efficacy and adverse effects of cannabis used for sickness induced by chemotherapy.
 

Design: Systematic review.

Data sources: Systematic search (Medline, Embase, Cochrane library, bibliographies), any language, to August 2000.

Studies: 30 randomised comparisons of cannabis with placebo or antiemetics from which dichotomous data on efficacy and harm were available (1366 patients). Oral nabilone, oral dronabinol (tetrahydrocannabinol), and intramuscular levonantradol were tested. No cannabis was smoked. Follow up lasted 24 hours.

Results: Cannabinoids were more effective antiemetics than prochlorperazine, metoclopramide, chlorpromazine, thiethylperazine, haloperidol, domperidone, or alizapride: relative risk 1.38 (95% confidence interval 1.18 to 1.62), number needed to treat 6 for complete control of nausea; 1.28 (1.08 to 1.51), NNT 8 for complete control of vomiting. Cannabinoids were not more effective in patients receiving very low or very high emetogenic chemotherapy. In crossover trials, patients preferred cannabinoids for future chemotherapy cycles: 2.39 (2.05 to 2.78), NNT 3. Some potentially beneficial side effects occurred more often with cannabinoids: “high” 10.6 (6.86 to 16.5), NNT 3; sedation or drowsiness 1.66 (1.46 to 1.89), NNT 5; euphoria 12.5 (3.00 to 52.1), NNT 7. Harmful side effects also occurred more often with cannabinoids: dizziness 2.97 (2.31 to 3.83), NNT 3; dysphoria or depression 8.06 (3.38 to 19.2), NNT 8; hallucinations 6.10 (2.41 to 15.4), NNT 17; paranoia 8.58 (6.38 to 11.5), NNT 20; and arterial hypotension 2.23 (1.75 to 2.83), NNT 7. Patients given cannabinoids were more likely to withdraw due to side effects 4.67 (3.07 to 7.09), NNT 11.

Conclusions: In selected patients, the cannabinoids tested in these trials may be useful as mood enhancing adjuvants for controlling chemotherapy related sickness. Potentially serious adverse effects, even when taken short term orally or intramuscularly, are likely to limit their widespread use.