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Naltrexone as anti-craving medication in cannabis addicts

Naltrexone as anti-craving medication in cannabis addicts - Naltrexone in cannabis addiction

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35633
Enrollment
60
Registered
2010-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

verslaving aan cannabis cannabis addiction

Interventions

Either Naltrexone 50 mg once daily for eight weeks. Or placebo once daily for eight weeks.

Sponsors

Centrum Maliebaan (Utrecht)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: male or female between 18 - 60 years old current primary diagnosis of cannabis abuse or dependence able to provide written informed consent and to comply with all study procedures

Exclusion criteria

Exclusion criteria: currently dependent on opiates currently majorly dependant on another substance other than cannabis or nicotine severe medical illness known allergy to Naltrexone

Design outcomes

Primary

MeasureTime frame
RESEARCH QUESTIONS AND HYPOTHESES a) In patients with predominantly cannabis addiction, does Naltrexone significantly reduce craving for cannabis, significantly reduce use of cannabis, significantly increase general well-being on the MATE-scale, and have a sginificant effect on the use of other addictive substances? b) Which are the side effects? c) Do the side effects cause people to stop taking the medication (Naltrexone or placebo)? 4.6 Baseline and Outcome Measures The initial assessment will entail the MATE-scale to establish the social and general functioning, a short depression questionnaire to rule out a depressive disorder, a thorough assessment of current cannabis use and the use of other addictive substances, validated questionnaires for subjective craving for cannabis (e.g. Desires for Drug Questionnaire, Obsessive Compulsive Drug Use Scale; Franken et al., 2002), a visual analogue scale for craving for cannabis (VAS; Franken and Muris, 2005), a VAS for craving for other addictive substances, blood pressure and pulse, basic blood lab of liver function and extra blood will be frozen for possible later research on genetic markers. At two, four, six and eight weeks the assessment will ential an assessment of the use of the medication, of cannabis use, of the use of other addictive substances, of side effects, a VAS of craving for cannabis and a VAS of craving for other addictive substances. At eight weeks the MATE-scale, blood pressure and pulse, and basic blood lab of liver function will also be measured. If at the conclusion of the study there are clear distinct outcomes, we might use the extra blood for research on genetic markers.

Secondary

MeasureTime frame
d) Are there genetic markers which can predict which patients are more likely to respond well to Naltrexone?

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)