A randomised controlled trial of a novel combination pharmacotherapy program for the treatment of cannabis dependence

A randomised double blind placebo controlled trial of combination pharmacotherapy using mirtazapine, acamprosate and tiagabine for the treatment of cannabis dependence

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000581268

Enrollment

120

Registered

2009-07-14

Start date

2009-08-10

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Cannabis is often a difficult drug to stop, and its regular use often causes dependence and withdrawal symptoms when attempting to stop. In Australia, the major treatment available for cannabis dependence is counselling, but many individuals find that counselling for cannabis use is not effective, particularly because of the withdrawal symptoms that occur. This project will assess a new treatment for cannabis dependence in patients who are seeking treatment to stop their cannabis use, and uses a combination of medications that aim to block the effects of cannabis withdrawal in the brain, and so reduce the severity of cannabis withdrawal symptoms. The three medications used in combination are tiagabine, acamprosate and mirtazapine. Participants will be allocated to one of two treatment groups. One treatment group will receive a combination of the three active medications, tiagabine, acamprosate and mirtazapine for a period of 12 weeks. The second treatment group will receive placebo (dummy) medications for 12 weeks. Allocation to either group will be by a randomisation process – like flipping a coin. All patients in the trial will also receive a program of weekly counselling and support. Patients will participate in the trial for a period of six months.

Interventions

Active 12 week pharmacological treatment arm using a combination of mirtazapine (30mg oral daily), acamprosate (999mg oral twice daily) and tiagabine (5mg oral twice daily) versus a placebo medication treatment arm. All subjects (active medication and placebo) also receive weekly, nurse-based, supportive counseling and assistance with pharmacological compliance and a 6 session manualised cognitive behavioral cannabis treatment program (1 session per week for 6 weeks)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

using cannabis daily for at least 3 months

Exclusion criteria

less than 18 years of age; inability to take oral medicaton; concurrent medical illness requiring acute care hospitalisation or treatment; severe renal or liver disease; pregnancy

Outcome results