Effects of fixed or self-titrated dosages of Sativex on cannabis withdrawal and cravings.
Open accessAbstract
Background There is currently no pharmacological treatment approved for cannabis dependence. In this proof of concept study, we assessed the feasibility/effects of fixed and self-titrated dosages of Sativex (1:1, Δ(9)-tetrahydrocannabinol (THC)/cannabidiol (CBD)) on craving and withdrawal from cannabis among nine community-recruited cannabis-dependent subjects.Methods Participants underwent an 8-week double-blind placebo-controlled trial (an ABACADAE design), with four smoke as usual conditions (SAU) (A) separated by four cannabis abstinence conditions (B-E), with administration of either self-titrated/fixed doses of placebo or Sativex (up to 108 mg THC/100 mg CBD). The order of medication administration during abstinence conditions was randomized and counterbalanced. Withdrawal symptoms and craving were assessed using the Cannabis Withdrawal Scale (CWS), Marijuana Withdrawal Checklist (MWC) and Marijuana Craving Questionnaire (MCQ). Medication use was assessed during the study by means of self-reports, vial weight control, toxicology and metabolite analysis. Cannabis use was assessed by means of self-reports.Results High fixed doses of Sativex were well tolerated and significantly reduced cannabis withdrawal during abstinence, but not craving, as compared to placebo. Self-titrated doses were lower and showed limited efficacy as compared to high fixed doses. Participants reported a significantly lower "high" following Sativex or placebo as compared to SAU conditions. Cannabis/medication use along the study, as per self-reports, suggests compliance with the study conditions.Conclusions The results found in this proof of concept study warrant further systematic exploration of Sativex as a treatment option for cannabis withdrawal and dependence.
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The THC/CBD mixture reduced withdrawal symptoms and improved retention in treatment in a clinical trial and a human laboratory study.
“was able to reduce withdrawal symptoms and improve retention in treatment in both a clinical trial 58 and a human laboratory study 59.”
From Psychosocial and pharmacological interventions for the treatment of cannabis use disorder (2018) · cites this paper as [59]
The Results (§3.4) show that fixed-dose Sativex reduced cannabis withdrawal compared with placebo in the human laboratory study. The paper does not report improved treatment retention in that study; its Introduction (§1) attributes the retention finding to an earlier clinical trial, while Results (§3.1) reports study completion without a retention comparison. (LLM, conf=0.87)
Experimental — accuracy not yet measuredThe THC/CBD mixture did not elicit greater reduction in cannabis use compared with placebo.
“despite not eliciting greater reduction in cannabis use when compared with placebo”
From Psychosocial and pharmacological interventions for the treatment of cannabis use disorder (2018) · cites this paper as [59]
The THC/CBD mixture does not elicit as much of a psychoactive effect as cannabis.
“Recent studies report that the THC/CBD mixture does not elicit as much of a psychoactive effect as cannabis”
From Psychosocial and pharmacological interventions for the treatment of cannabis use disorder (2018) · cites this paper as [59]
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- Authors
- Trigo, J. M., Lagzdins, D., Rehm, J., Selby, P., Gamaleddin, I., Fischer, B., Barnes, A. J., Huestis, M. A., & Le Foll, B.
- Affiliations
- Centre for Addiction and Mental Health (CA)
- Ain Shams University (EG)
- National Institutes of Health (US)
- Venue
- Drug and Alcohol Dependence
- Publisher
- Elsevier BV
- Published
- 2016-04
- Volume
- 161
- Pages
- 298-306
- ISSN
- 0376-8716 (ISSN-L)
- PMC
- PMC4878903
- OpenAlex
- W2276226615
- Cited by
- 97
- References
- 71
- Citations by year
- 2026: 4 · 2025: 4 · 2024: 7 · 2023: 11 · 2022: 13 · 2021: 13 · 2020: 9 · 2019: 10 · 2018: 14 · 2017: 8 · 2016: 4
- FWCI
- 9.70
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Drug and Alcohol Dependence (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Canadian Institutes of Health Research (115548_1)
- Topics
- Health Sciences › Medicine › Pharmacology › Cannabis and Cannabinoid Research
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Physiology › Smoking Behavior and Cessation
- Keywords
- Sativex, cannabis use disorder, cannabis withdrawal, cannabis craving, THC, cannabidiol, cannabis abstinence, treatment efficacy, tolerability
- MeSH terms
- Adult, Cannabidiol, Cannabis, Marijuana Abuse, Double-Blind Method, Drug Combinations, Female, Humans, Male, Marijuana Smoking, Middle Aged, Plant Extracts, Substance Withdrawal Syndrome, Dronabinol, Treatment Outcome, Substance-Related Disorders, Young Adult, Craving
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