Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201310000589295 Date of Approval: 12/07/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Psychosocial Treatment for Methamphetamine Use Disorders in South Africa: A Pilot Study of a Cognitive Behavioural Therapy Program
Official scientific title Psychosocial Treatment for Methamphetamine Use Disorders in South Africa: A Pilot Study of a Cognitive Behavioural Therapy Program
Brief summary describing the background and objectives of the trial Methamphetamine use disorders have increasingly become a concern in South Africa, particularly in the Western Cape Province. Yet, despite its widespread use and associated problems, treatments with known efficacy are not widely available in South Africa and other low and middle income settings. Therefore, the aim of the present study is to determine the feasibility, acceptability and effectiveness of a 6 session CBT intervention for South Africans with methamphetamine (MA) use disorders.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Project TIME
Disease(s) or condition(s) being studied Methamphetamine Use Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2013
Actual trial start date 01/07/2013
Anticipated date of last follow up 31/05/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control Group undefined undefined treatment as usual- referral to specialized services 30 Active-Treatment of Control Group
Experimental Group CBT 7 sessions, once a week 1 hour A modified 7 session CBT intervention 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Between 18 and 65 years of age -Must meet DSM-IV criteria for methamphetamine abuse or dependence according to the Mini-International Psychiatric Interview (MINI) substance use module -Methamphetamine must be their drug of choice. - Patients can have comorbid substance use disorders will not be excluded. -Exclusion criteria will include bipolar disorder, suicidality, schizophrenia and antisocial personality disorder (as assessed on the MINI). 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/02/2013 URC- Health Sciences University of Cape Town
Ethics Committee Address
Street address City Postal code Country
Room E52-24 Groote Schuur Hospital Observatory 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Frequency of methamphetamine use (days per week) validated with drug tests -baseline -7 weeks following baseline -3 months post treatment
Secondary Outcome Methamphetamine Cravings - baseline - 7 weeks after baseline (post-treatment) -3 months post treatment
Secondary Outcome Severity of Meth Use Disorder - 7 weeks after baseline (post-treatment) -3 months post treatment
Secondary Outcome Depression - baseline - 7 weeks after baseline (post-treatment) -3 months post treatment
Secondary Outcome Anxiety - baseline - 7 weeks after baseline (post-treatment) -3 months post treatment
Secondary Outcome Disability - baseline - 7 weeks after baseline (post-treatment) -3 months post treatment
Secondary Outcome Quality of LIfe - baseline - 7 weeks after baseline (post-treatment) -3 months post treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kensington Treatment Centre Kensington St. Maitland 7404 South Africa
Groote Schuur Hospital Observatory 7925 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Psychiatry & Mental Health, University of Cape Town J2 Groote Schuur Hospital Anzio Rd. South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of Psychiatry & Mental Health, University of Cape Town J2 Groote Schuur Hospital Observatory South Africa University
COLLABORATORS
Name Street address City Postal code Country
Prof. D Stein J2 Groote Schuur Hospital Anzio Rd. South Africa
Prof. John Grant 5841 S, Maryland Ave Chicago MC 3077 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Katherine Sorsdahl katherine.sorsdahl@uct.ac.za 021 650 6567 J2 Groote Schuur Hospital
City Postal code Country Position/Affiliation
Anzio Rd. South Africa
Role Name Email Phone Street address
Public Enquiries Katherine Sorsdahl katherine.sorsdahl@uct.ac.za 021 650 6567
City Postal code Country Position/Affiliation
Role Name Email Phone Street address
Scientific Enquiries Katherine Sorsdahl katherine.sorsdahl@uct.ac.za 021 650 6567
City Postal code Country Position/Affiliation
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information