Condition category
Mental and Behavioural Disorders
Date applied
25/08/2015
Date assigned
28/08/2015
Last edited
28/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Heroin and crack cocaine are amongst the most addictive drugs on the market, and are two of the most commonly treated drug problems by the NHS in England. In many cases however, treatment is do not work, as the drug is being taken by the user at the same time as they are being treated. There are currently no NICE-approved medications for people who are dependent on cocaine available, and the existing talking therapies that are provided have not been found to be particularly effective for routine users. National outcome monitoring data for England shows that 60% of heroin users and 70% of cocaine users continue to use these drugs after 6 months of treatment, and so better treatments are urgently required. ‘Craving’ is considered to be one of the most important parts of addiction, and the main reason for continued use and relapse. Similarities have been found between these the behaviour accompanying these cravings and to the behaviour of people suffering from post-traumatic stress disorder (PTSD). It may therefore be possible to adapt memory consolidation techniques (a process of changing memories stored in the long-term memory) used in cognitive behavioural therapy for people with PTSD, to target cravings. This study aims to find out whether these techniques could be used to reduce the intensity of cravings in cocaine dependant individuals.

Who can participate?
Adults with a current diagnosis of cocaine dependence who want to reduce or quit taking cocaine.

What does the study involve?
At the start of the study, all participants take a questionnaire in order to find out how intense their craving is. Participants are then randomly divided into two groups. The first group (experimental group) takes part in a five day memory reconsolidation (to modify the “positive” memories of the effects of the drug) and cognitive restructuring (learning to identify and resist irrational thoughts) protocol. The second group (control group) receives no intervention. The questionnaire about their craving intensity is then repeated after one week and after four weeks.

What are the possible benefits and risks of participating?
A potential benefit is that the participants in the experimental group will be taking part in a new protocol that is designed to make them more aware of the things that trigger their drug use and may be able to have greater control over their cravings. There are risks to participants because the study is intended to induce urges to use cocaine and in order to investigate assess craving reduction over the course of the study. There are measures in place to help the participants however, such as receiving a ‘talk down’ session so that they will not leave until the cravings have subsided, as well as being offered transport home.

Where is the study run from?
1. Beresford Project, South London and Maudsley NHS Foundation Trust (UK)
2. Lorraine Hewitt House, South London and Maudsley NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
June 2016 to February 2016

Who is funding the study?
Kings College London, Biomedical Research Centre (UK)

Who is the main contact?
Mr Garry Stillwell
garry.stillwell@kcl.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mr Garry Stillwell

ORCID ID

Contact details

Institute of Psychiatry
King's College London
Addiction Sciences building
4 Windsor Walk
London
SE5 8AF
United Kingdom
+44 20 7848 0901
garry.stillwell@kcl.ac.uk

Type

Scientific

Additional contact

Prof John Marsden

ORCID ID

http://orcid.org/0000-0002-1307-2498

Contact details

Addictions Department
Institute of Psychiatry
Psychology & Neuroscience
Addiction Sciences Building
4 Windsor Walk
London
SE5 8AF
United Kingdom
+44 20 7848 0830
john.marsden@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1.0

Study information

Scientific title

Pilot Feasibility Study of Cognitive control in cocaine dependence: A multi-centre randomized controlled trial to pilot targeting craving for cocaine using memory reconsolidation techniques

Acronym

Study hypothesis

This pilot study has two aims:
1. To evaluate the feasibility of our research data collection, craving cue-reactivity and cognitive restructuring methods
2. To ascertain the clinically meaningful effect on craving intensity arising from our addiction cognitive control intervention to inform a formal randomized controlled trial.

Ethics approval

National Research Ethics Service Committee, Fulham (London), 12/05/2015, ref: 15/LO/0656

Study design

Multi-centre randomized controlled pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Cocaine dependence

Intervention

Informed, consenting adult participants will be randomised remotely by the Clinical Trials Unit Kings College, London to one of two conditions:
Experimental Group: BExperiment: 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.
Control Group: Baseline and repeated cocaine craving provocation, assessment and research follow-ups at 1 and 4 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.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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 measures

1. Physiological parameters during the craving provocation and memory reconsolidation and cognitive restructuring sessions: blood pressure, pulse rate, heart rate variability, respiration, oxygen saturation and temperature, electrodermal activity and skin conductance response. . Mean and peak values will be computed: Days 1 to 5 of intervention period.
2. Self-report of cocaine use. We will use a modified time-line follow-back (calendar prompt) interview to record instances of cocaine use during the study at weeks 1 and 4 post randomization.
3. Urine toxicology screening (UDS). By instant result immunoassay device for cocaine metabolite (benzolyecgonine) and morphine (morphine 2000 assay). At weeks 1 and 4 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. We will record the number of experimental participants who complete the 5-day CRF programme.

Overall trial start date

01/06/2015

Overall trial end date

28/02/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Current diagnosis of post-traumatic stress disorder (DSM-5)
2. Current non-medical benzodiazepine or harmful alcohol use (>50 units per week men; >35 units women)
3. Use of heroin or cocaine in the 24 hours before first CRF session
4. Clinically significant on-going medical problems that might make participation unsafe
5. Acute housing instability
6. Uncontrolled serious psychiatric illness
7. Significant neuro-cognitive functioning (<18, Montreal Cognitive Assessment)
8. Pregnant or breast feeding
9. Current enrollment in an addiction treatment related clinical research study

Recruitment start date

01/06/2015

Recruitment end date

30/10/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Beresford Project
South London and Maudsley NHS Foundation Trust 36-42 Hare Street Woolwich
London
SE18 6LZ
United Kingdom

Trial participating centre

Lorraine Hewitt House
South London and Maudsley NHS Foundation Trust 12-14 Brighton Terrace Brixton
London
SW9 8DG
United Kingdom

Sponsor information

Organisation

Kings College London

Sponsor details

King's College London
Strand
London.
WC2R 2LS
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Kings College London (Biomedical Research Centre)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Two papers will be published in a peer review journal (to be determined). 1. The study protocol – target date Dec 2015; 1. Study findings – target date Jun 2016

Intention to publish date

01/12/2015

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes