Randomised control trial of monoamine precursors for the treatment of psychostimulant withdrawal

A double-blind, randomised, placebo controlled trial of monoamine precursors in the treatment of psychostimulant withdrawal in adult humans seeking treatment for psychostimulant use

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000094471

Acronym

Monoamine precursor trial

Enrollment

100

Registered

2007-01-29

Start date

2007-01-31

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 study aims to: identify the safety and acceptability of monoamine precursor provision in the management of psychostimulant withdrawal; explore the impact of monoamine precursor provision on engagement and retention in treatment; research the effect of monoamine precursor provision on the clinical course and severity of psychostimulant withdrawal; and, explore the impact of monoamine precursor provision in improving abstinence rates.

Interventions

Oral monoamine precursors (5-HTP (300mg daily), L-tyrosine (1500mg daily), dl-phenylalanine (2000mg daily)) and oral multivitamins (3 tablets daily, one multivitamin tablet is on average in the range of 1200mg – 1400mg). All participants will be offered 4 weekly sessions of outpatient cognitive behavioural therapy (CBT) of approximately one hour duration each.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

Inclusion Criteria 1. DSM-IV Classification of Amphetamine or Cocaine Dependence / Severity of Dependence Scale (SDS) score greater than 4. 2. Psychostimulant use at least 2 times per week with at least 3 month history.

Exclusion criteria

Exclusion Criteria 1.Alcohol dependence (AUDIT) 2. Use of drugs other than psychostimulants 4 times a week or more (nicotine dependence is permitted)3. Amino acid contraindications (eg., phenylketonuria) 4. Malabsorption medical conditions (eg., Crohn’s disease, ulcerative colitis) 5. Currently prescribed antidepressant / mood stabilising / antipsychotic medications 6. Current suicidal ideation 7. History of schizophrenia / other psychotic illness 8. Hospitalisation in the past 12 months for more than 24 hours for psychiatric symptoms including hallucinations, delusions and suicidal ideation 9. Elevated Liver Function Tests (3 times higher than normal levels) 10. Currently pregnant or likely to become pregnant in the following month.

Outcome results