NCT03656653

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 30, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

February 28, 2019

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

August 22, 2018

Last Update Submit

February 26, 2019

Conditions

Cocaine Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Changes in Number of Days abstinent from Cocaine

    The primary outcome measure will be number of days abstinent from cocaine (percentage). A higher percentage indicates a higher number of abstinent days from cocaine. This will be expressed as the cumulative distribution function for change (between baseline and follow-up) using a Timeline Follow Back method (calendar prompt). Percentage days abstinent is measured for two weeks before the first assessment and two weeks post craving-induction procedure.

    baseline (Week 0) and at two week-follow up (Week 4)

Secondary Outcomes (13)

  • Change from baseline in Craving Experience Questionnaire Score (CEQ-12)

    baseline (Week 0) and at two week-follow up (Week 4)

  • Urine toxicology Screening (UDS)

    Assessed at two-week follow up (Week 4)

  • Imagery Monitoring Diary

    Diary assessed at two-week follow up (Week 4)

  • Heart Rate Variability (HRV)

    Week 2; 2 hour session

  • Electrodermal Activity (EDA)

    Week 2; 2 hour session

  • +8 more secondary outcomes

Study Arms (4)

Future-based recovery-oriented imagery

EXPERIMENTAL

Mental Imagery for Craving Reduction: mental imagery aimed at describing a future without cocaine use

Behavioral: Mental Imagery for Craving Reduction

Future-based cocaine-aversive imagery

EXPERIMENTAL

Mental Imagery for Craving Reduction: mental imagery aimed at describing a future where cocaine is causing significant distress

Behavioral: Mental Imagery for Craving Reduction

Past recovery-oriented imagery

EXPERIMENTAL

Mental Imagery for Craving Reduction: mental imagery aimed at describing a past event without cocaine use

Behavioral: Mental Imagery for Craving Reduction

Past cocaine-aversive imagery

EXPERIMENTAL

Mental Imagery for Craving Reduction: mental imagery aimed at describing a past event where cocaine use has caused significant distress

Behavioral: Mental Imagery for Craving Reduction

Interventions

Mental Imagery for Craving ReductionBEHAVIORAL

a behavioural mental imagery intervention where participants are asked to generate specific mental images to reduce cue-induced craving for cocaine use disorder

Future-based cocaine-aversive imageryFuture-based recovery-oriented imageryPast cocaine-aversive imageryPast recovery-oriented imagery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (18 years and over; no upper limit);
  • English speaking (to a level sufficient to engage with a psychosocial intervention);
  • Current diagnosis for primary CUD alone, with concurrent opiate use disorder or while enrolled in opioid agonist therapy \*
  • Self-reported regular use of crack cocaine;
  • Stated motivation to reduce or quit cocaine use;

You may not qualify if:

  • Current post-traumatic stress disorder (PTCI score \>100);
  • Suicide attempt in the past 3 months;
  • Participants with harmful alcohol consumption (\>50 units per week men; \>35 units women);
  • Cocaine hydrochloride (powder form) users; \*\*
  • Non-English Speaking;
  • Clinically significant on-going medical problems that might make participation unsafe;
  • Uncontrolled Mental Health Disorder;
  • Severe neurocognitive impairment (Montreal Cognitive Assessment \<17);
  • Current enrolment in an addiction treatment related clinical research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lorraine Hewitt House

London, SW9 8DG, United Kingdom

RECRUITING

Study Officials

  • John Marsden

    King's College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Camille Goetz

CONTACT

00447928331625camille.e.goetz@kcl.ac.uk

John Marsden

CONTACT

004420 7848 0830john.marsden@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2018

First Posted

September 4, 2018

Study Start

October 30, 2018

Primary Completion

January 30, 2020

Study Completion

September 30, 2020

Last Updated

February 28, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)