A double-blinded, placebo-controlled trial of modafinil for amphetamine withdrawal

A double-blinded, placebo-controlled trial of modafinil for amphetamine withdrawal in adults who are currently dependent on amphetamines

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000272594

Acronym

Modafinil Study

Enrollment

Registered

2006-07-03

Start date

2006-07-01

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

The project aims to develop a greater understanding of amphetamine withdrawal and whether medication, such as modafinil, is effective in the management of amphetamine withdrawal in an inpatient setting. Participants will be randomised to a single morning dose of modafinil or matching placebo. Participants will receive medication for seven days (tapering doses from 200mg to 100mg). The two treatment groups will be compared for their symptoms of amphetamine withdrawal, including symptoms of depression and sleep disturbance, neuro-cognitive function, as well as any potential side effects from the medication. Other outcome measures will include retention in treatment and monitoring the rate of relapse to amphetamine use post withdrawal. This information will then inform guidelines for withdrawal management, including psychosocial and medical aspects. The protocol will be distilled for a clinical audience and include principles and practice, practice guidelines and recommendations for implementation

Interventions

Participants will be recruited via UnitingCare Moreland Hall and Drug and Alcohol Services, Western Hospital (DASWest). Participants will receive oral modafinil for seven days (tapering doses from 200mg for the first 5 days to 100mg for days 6 and 7).

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

Meets the Diagnostic and Statistical Manual for Mental Disorders No. 4 (DSM-IV) diagnosis of current amphetamine dependence, Has used amphetamines in previous 48 hours, Is seeking treatment for amphetamine dependence, Is willing and able to give informed consent.

Exclusion criteria

Currently dependent on other psychoactive drugs other than amphetamines, cannabis or nicotine, Has any significant unstable medical conditions, Is pregnant or breastfeeding, Is suffering from active psychosis or current major depression, Is diagnosed with attention deficit hyperactivity disorder or narcolepsy, Is known to have had an allergic reaction to modafinil previously, Has had treatment with dexamphetamine or modafinil in the previous month.

Outcome results