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. 2023 Jun 5;2023(6):CD014915. doi: 10.1002/14651858.CD014915.pub2

Jochimsen 1978.

Study characteristics
Methods Purpose of the study: to assess the analgesic activity of a synthetic THC analogue at 2–4 mg
Study setting: 1 university hospital in USA
Study period: not reported
Study design: double‐blind, randomised, placebo‐controlled, cross‐over design
Study duration: 1 day each. Regular medication was stopped 4 hours before the intake of the medication
Participants Type of cancer: no details reported
Inclusion criteria: pain related to malignancies and history of frequent analgesic use, though 1 had received large doses of narcotics
Exclusion criteria: conditions interfering with drug metabolism, severe organic disease other than cancer, pregnancy or major psychiatric disorders
Synthetic THC analogue: 35 participants; 17% men; aged 38–77 years; race: not reported; type of cancer pain: not reported; pain medication: not reported; previous cannabis use: not reported
Interventions Synthetic nitrogen‐containing benzopyran derivative (modification of delta‐I‐trans‐THC): 2 mg and 4 mg single, fixed dosage PO
Codeine: 60 mg and 120 mg single, fixed dosage PO
Placebo: PO
Rescue medication: none
Allowed cotherapies: no details reported
Outcomes Proportion of participants reporting no worse than mild pain on treatment at 14 days after start of treatment (typically < 30/100 mm on a 100‐mm VAS or < 3 on an 11‐point NRS): not assessed
Patient impression to be much or very much improved: not assessed
Withdrawal due to adverse events: no details of assessment reported
Combined responder: not assessed
Pain relief ≥ 30%: not reported; imputation method not applicable because baseline pain scores not reported. Number of participants with moderate pain relief reported
Pain relief ≥ 50%: reported
Mean pain intensity: hourly ratings of the severity of pain (0, absent; 1, mild; 2, moderate; 3, severe) were used to determine hourly pain reduction scores
Sleep problems: not assessed
Depression: not assessed
Anxiety: not assessed
Daily maintenance opioid therapy dose: not assessed
Daily breakthrough opioid therapy dose: not assessed
Withdrawals due to lack of efficacy: not reported
Nervous system disorders adverse effects: at hourly intervals, the participant completed an 11‐item subjective effects questionnaire, designed to quantify certain psychic manifestations of the test preparations. Data provided not suited for analysis.
Psychiatric disorders adverse effects: at hourly intervals, the participant completed an 11‐item subjective effects questionnaire, designed to quantify certain psychic manifestations of the test preparations. Data provided not suited for analysis.
Any serious adverse event: not assessed
Notes Funding: grant RR‐59 from the General Clinical Research Canters Program Division of Research Resources, National Institutes of Health and Abbott Laboratories.
Conflicts of interest: not declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details reported.
Allocation concealment (selection bias) Unclear risk No details reported.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "Identical appearing capsules."
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No details reported.
Incomplete outcome data (attrition bias)
All outcomes High risk Responder analysis.
Selective reporting (reporting bias) Unclear risk No prepublished study protocol available.
Selection bias Low risk Identical baseline parameters of the study groups due to cross‐over design.