Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03656653
Status:
UNKNOWN
Last Update Posted:
2019-02-28
First Post:
2018-08-22
Brief Title:
Imagery-based Coping for Cocaine Use Disorder
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Clinical Study of Imagery-based Coping for Cocaine Use Disorder
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIIC
Brief Summary:
A pragmatic 4-week 4-group between-subjects factorial randomised controlled trial conducted at a specialist NHS outpatient addictions clinic and hospital clinical research facility to determine if mental imagery of past and future positive recovery oriented and negative cocaine aversive events can help reduce cue-induced cocaine craving and cocaine use
Detailed Description:
Cocaine a powerful stimulant drug is used by 22 of people aged 16-59 in England and each year about 150000 people seek help for cocaine use disorder from the NHS or non-governmental organisations NGO There are currently no approved medication-assisted treatments or specific psychosocial interventions for CUD General counselling is offered by the NHS and NGO addiction services but this is not particularly effective
The transition from regular cocaine use to cocaine abuse is often marked by intense episodes binges which may last several days and are followed by a crash with no or little use For many people repeated administration of cocaine over a short duration of time creates vivid episodic memories of euphoria which can inform future craving content Craving or strong urges are a distinctive feature of CUD and are often reported as involuntary distressing and uncontrollable
Research has demonstrated that craving experiences can be voluntarily evoked or elicited by conditioned drug cues in the environment and internal processes such mood or physical sensations The associations between cues and use are established through classical and instrumental reward-based conditioning and are important for the development and maintenance of CUD Enhanced attention to cocaine cues develops and remains heightened for at least six months into abstinence
Craving-related experiences are informed by memories of intense reward physical sensations and include pro-drug beliefs appraisals expectancies and vivid mental imagery Drug-imagery is often initially pleasurable and affectively charged and can motivate drug-seeking behaviour If impeded or delayed drug imagery highlights a deficit and can be experienced as distressing and intrusive Treatment of intrusive images has been successful in various psychological disorders using imagery rescripting Imagery rescripting has recently been used in memory-focused cognitive therapy to help reduce cocaine craving Reducing intrusive image-induced negative affect through positive imagery is important for relieving psychological distress but there is also evidence that aversive imagery may reduce maladaptive approach behaviours
This will be a pragmatic 4-week 2x2 between-subjects factorial randomised controlled trial It will be conducted at a specialist NHS outpatient addictions clinic Lorraine Hewitt House LHH operated by South London and Maudsley NHS Foundation trust SLaM and at the NIHR Wellcome Trust Kings Clinical Research Facility CRF at Kings College Hospital
Informed consenting adult participants will be randomised to one of four conditions
future-based prospective recovery-oriented imagery
future-based prospective cocaine-aversive imagery
past autobiographical recovery-oriented imagery or
past autobiographical cocaine-aversive imagery
Participants will undergo a craving induction procedure designed to elicit cue-induced craving In response to elevated craving participants will be asked to reduce their craving levels using a mental imagery intervention
Following the procedure in the research facility participants will be given a digital audio player to take home This will contain a recording of the imagery condition they are allocated to Participants will be asked to listen to this recording each day during a 14-day follow-up and ad libertatem when experiencing cocaine craving After 14 days participants will be invited for a follow up conducted at the community addictions clinic
The transition from regular cocaine use to cocaine abuse is often marked by intense episodes binges which may last several days and are followed by a crash with no or little use For many people repeated administration of cocaine over a short duration of time creates vivid episodic memories of euphoria which can inform future craving content Craving or strong urges are a distinctive feature of CUD and are often reported as involuntary distressing and uncontrollable
Research has demonstrated that craving experiences can be voluntarily evoked or elicited by conditioned drug cues in the environment and internal processes such mood or physical sensations The associations between cues and use are established through classical and instrumental reward-based conditioning and are important for the development and maintenance of CUD Enhanced attention to cocaine cues develops and remains heightened for at least six months into abstinence
Craving-related experiences are informed by memories of intense reward physical sensations and include pro-drug beliefs appraisals expectancies and vivid mental imagery Drug-imagery is often initially pleasurable and affectively charged and can motivate drug-seeking behaviour If impeded or delayed drug imagery highlights a deficit and can be experienced as distressing and intrusive Treatment of intrusive images has been successful in various psychological disorders using imagery rescripting Imagery rescripting has recently been used in memory-focused cognitive therapy to help reduce cocaine craving Reducing intrusive image-induced negative affect through positive imagery is important for relieving psychological distress but there is also evidence that aversive imagery may reduce maladaptive approach behaviours
This will be a pragmatic 4-week 2x2 between-subjects factorial randomised controlled trial It will be conducted at a specialist NHS outpatient addictions clinic Lorraine Hewitt House LHH operated by South London and Maudsley NHS Foundation trust SLaM and at the NIHR Wellcome Trust Kings Clinical Research Facility CRF at Kings College Hospital
Informed consenting adult participants will be randomised to one of four conditions
future-based prospective recovery-oriented imagery
future-based prospective cocaine-aversive imagery
past autobiographical recovery-oriented imagery or
past autobiographical cocaine-aversive imagery
Participants will undergo a craving induction procedure designed to elicit cue-induced craving In response to elevated craving participants will be asked to reduce their craving levels using a mental imagery intervention
Following the procedure in the research facility participants will be given a digital audio player to take home This will contain a recording of the imagery condition they are allocated to Participants will be asked to listen to this recording each day during a 14-day follow-up and ad libertatem when experiencing cocaine craving After 14 days participants will be invited for a follow up conducted at the community addictions clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None