Abstract
Introduction
Cocaine use disorder (CUD) is a debilitating condition characterised by maladaptive cocaine-related memories and impaired cognitive and behavioural control. There are no evidence-supported pharmacotherapies and only weakly effective psychological interventions specific for CUD. Our novel Memory-focused Cognitive Therapy (MFCT) aims to modify cocaine-related memories to reduce craving and drug use.
Methods
This is a single-centre (outpatient), 15-week, two-arm, pilot randomised controlled trial (RCT) to address feasibility, safety, quality and preliminary efficacy. Thirty participants (adults ≥18 years; current CUD) will receive ongoing standard care (treatment-as-usual [TAU]) during the study and will be randomised (1:1) to a control or intervention group. The control group will receive 3 × 90min CUD cognitive case conceptualisation assessments and 2 × 30min cocaine-related cue-induction procedures (in vivo presentation of images and objects). Experimental group participants will receive 3 × 90min CUD cognitive case conceptualisation assessments; 2 × 30min cue-induction procedures; and individual MFCT (5 × 120min; daily for 1 week; with 3 relapse prevention follow-ups over 3-months). All study participants will complete research follow-ups at 1-week, 1-month and 3-months. The experimental and control groups will be compared on the mean score on the frequency version of the Craving Experience Questionnaire at 1-month (primary outcome measure). Secondary outcomes include: percentage of days abstinent and longest period of continuous abstinence from cocaine (past 28-days at 1-month follow-up); urine drug screen and CUD diagnosis (DSM-5).
Conclusions
We will conduct a full external pilot RCT of a novel, MFCT for CUD. The findings will inform the case, and necessary modifications, for a substantive study.
Cocaine use disorder (CUD) is a debilitating condition characterised by maladaptive cocaine-related memories and impaired cognitive and behavioural control. There are no evidence-supported pharmacotherapies and only weakly effective psychological interventions specific for CUD. Our novel Memory-focused Cognitive Therapy (MFCT) aims to modify cocaine-related memories to reduce craving and drug use.
Methods
This is a single-centre (outpatient), 15-week, two-arm, pilot randomised controlled trial (RCT) to address feasibility, safety, quality and preliminary efficacy. Thirty participants (adults ≥18 years; current CUD) will receive ongoing standard care (treatment-as-usual [TAU]) during the study and will be randomised (1:1) to a control or intervention group. The control group will receive 3 × 90min CUD cognitive case conceptualisation assessments and 2 × 30min cocaine-related cue-induction procedures (in vivo presentation of images and objects). Experimental group participants will receive 3 × 90min CUD cognitive case conceptualisation assessments; 2 × 30min cue-induction procedures; and individual MFCT (5 × 120min; daily for 1 week; with 3 relapse prevention follow-ups over 3-months). All study participants will complete research follow-ups at 1-week, 1-month and 3-months. The experimental and control groups will be compared on the mean score on the frequency version of the Craving Experience Questionnaire at 1-month (primary outcome measure). Secondary outcomes include: percentage of days abstinent and longest period of continuous abstinence from cocaine (past 28-days at 1-month follow-up); urine drug screen and CUD diagnosis (DSM-5).
Conclusions
We will conduct a full external pilot RCT of a novel, MFCT for CUD. The findings will inform the case, and necessary modifications, for a substantive study.
| Original language | English |
|---|---|
| Pages (from-to) | 264-273 |
| Journal | Contemporary Clinical Trials Communications |
| Volume | 8 |
| Early online date | 2 Nov 2017 |
| DOIs | |
| Publication status | Published - Dec 2017 |