Pilot Feasibility Study of Cognitive Control in Cocaine Dependence

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2015
INTERVENTION: Informed, consenting adult participants will be randomised remotely by the Clinical Trials Unit Kings College, London to one of two conditions: Experimental Group: Experiment: Baseline cocaine craving provocation and assessment: research follow‐ups at 1 and 4 weeks. After baseline assessment experimental participants will be encouraged to ‘relive’ craving and cocaine use memories followed in week 1 by a 5‐day memory reconsolidation and cognitive restructuring protocol targeting repeated cocaine craving. Research follow‐ups at 1 and 4 weeks, and at 12 weeks. Control Group: Baseline and repeated cocaine craving provocation, assessment and research follow‐ups at 1 and 4 weeks, and at 12 weeks A ‘talk down’ procedure will be undertaken at the end of each session to ensure a participant does not leave a research session until any cravings induced are negated. CONDITION: Cocaine dependence ; Mental and Behavioural Disorders ; Cocaine dependence PRIMARY OUTCOME: Change in craving intensity. Measured using the craving experience questionnaire (CEQ‐11), adapted for cocaine for this study, at weeks 1 and 4 post randomization. SECONDARY OUTCOME: 1. Physiological parameters during the craving provocation and memory reconsolidation and cognitive restructuring sessions: pulse rate, heart rate variability, electrodermal activity and skin conductance response. Mean and peak values will be computed: Days 1 to 5 of the intervention period; 2. Self‐report of cocaine useis assessed using a modified time‐line follow‐back (calendar prompt) interview to record instances of cocaine use during the study at weeks 1, 4 and 12 post randomization; 3. Urine toxicology screening (UDS). By instant result immunoassay device for cocaine metabolite (benzolyecgonine) and morphine (morphine 2000 assay) at weeks 1, 4 and 12 post randomization and days 1 to 5 of the intervention; 4. Audio‐visual recordings: On a voluntary basis, each CRF session will be audio and video recorded via CCTV at the CRF; 5. Treatment retention is assessed by recording the number of experimental participants who complete the 5‐day CRF programme INCLUSION CRITERIA: 1. Adult (between 18 and 50 years old) 2. English speaking 3. Current diagnosis for cocaine dependence (ICD‐10) 4. Self‐reported regular cocaine use (weekly) and cocaine‐positive UDS during screening 5. Motivation to reduce or quit cocaine use
Epistemonikos ID: 2563f90c0c75031194bac351df70c9907123bce1
First added on: Aug 23, 2024