|- candidate number||26855|
|- NTR Number||NTR6253|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mrt-2017|
|- Secondary IDs||2015-DP 4666 METC UvA|
|- Public Title||Exploration of implicit biases in adults who are current cocaine users|
|- Scientific Title||Web-based cognitive bias modification in South African cocaine users|
|- ACRONYM||CBM Cocaine SA|
|- hypothesis||1. A decrease in cocaine use over a three month period in participants who receive AAT training as opposed to VPT training.|
2. A change in symptoms involving craving, the urge to use, withdrawals well as stated readiness to change in participants receiving either AAT or VPT training as opposed to the participants in the placebo group.
3. A correlation between a decrease in cocaine use and the use of CBT coping skills as opposed to meditation-based coping skills.
4. No relationship between Race (Black, White, Mixed race or Colored, Indian) and an outcome defined as reduced cocaine use.
|- Healt Condition(s) or Problem(s) studied||Cocain addiction|
|- Inclusion criteria||Self-rated fluency in English; Age 18-65; Willingness to participate|
|- Exclusion criteria||History of head injury; color-blindness; photo-sensitive epilepsy|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||4-nov-2015|
|- planned closingdate||31-jul-2017|
|- Target number of participants||160|
|- Interventions||The participants are assessed at intake to determine their level of attentional bias (AB) and approach bias (AAT) to pictorially presented cocaine-related stimuli. Thereafter, they undergo a six-week training component in either attentional bias modification or approach bias modification. They are re-assessed at six weeks and three months post-treatment.|
|- Primary outcome||A reduction in the number of lines of cocaine used in the past two weeks as measured by a two-week Time Line Feedback (TLFB).|
|- Secondary outcome||An increase in the use of effective coping skills.|
A decrease in symptoms relating to a decrease in cocaine use.
A decrease over time of both attentional bias and approach bias to cocaine-realted stimuli in both the AAT and AB groups.
|- Timepoints||Intake, six weeks post-treatment; three months post-treatment.|
|- Trial web site||www.iquitcocaine.com|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Evelyn Beneke|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Reinout Wiers|
|- Sponsor/Initiator ||University of Amsterdam (UvA)|
(Source(s) of Monetary or Material Support)
|- Brief summary||This research is the first online study targeting cocaine use in South Africa and involving all race groups. Cocaine use is extremely prevalent in urban milieux in South Africa.|
|- Main changes (audit trail)|
|- RECORD||10-mrt-2017 - 3-mei-2017|