Additction Recovery Clinic (ARC) - Adaptive Maintenance Treatment for Opioid Use Disorder.

• Register: EUCTR
• Last refreshed on: 22 April 2013
• Main ID: EUCTR2012-002237-11-GB
• Date of registration: 18/09/2012
• Prospective Registration: Yes
• Primary sponsor: King's College London
• Public title: Additction Recovery Clinic (ARC) - Adaptive Maintenance Treatment for Opioid Use Disorder.
• Scientific title: Effectiveness of Adaptive Opioid Agonist Maintenance Pharmacotherapy and Behavioural Therapy for Opioid Use Disorder. - Addiction Recovery Clinic (ARC)
• Date of first enrolment: 17/12/2012
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002237-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

United Kingdom

Contacts

• Name: Michael Kelleher
• Affiliation: South London & Maudsley NHS Foundation Trust

• Name: Michael Kelleher
• Affiliation: South London & Maudsley NHS Foundation Trust

Key inclusion & exclusion criteria

Inclusion criteria:
18 years of age or older (no upper limit, but generally <60yrs).
Is able to comprehend English to the extent required by the study protocol
Demonstrates verbal understanding of the study patient information material, is able to provide written consent, and can understand and confirm willingness to comply with the protocol.
Current diagnosis of opioid use disorder (dependence)
Current opioid tolerance
Prescribed either methadone or suboxone
Voluntarily seeking treatment for opioid dependence and able to attend the clinic as described in the protocol.
Lives in sufficiently stable accommodation in the community, with a personal phone
Can nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number which we can call to assist as necessary with the arrangement of follow-up appointments.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Clinically significant medical condition including but not limited to: uncontrolled hypertension; significant heart disease (including myocardial infarction in past 12 months); angina; or any serious, potentially life-threatening or progressive medical illness other than addiction that may compromise subject safety or study conduct; or any abnormality which, in the investigator’s judgment, is clinically significant.
Current criminal justice involvement with legal proceedings and, in the opinion of the Chief Investigator, is expected to fail to complete the study protocol due to incarceration or relocation from the centre’s catchment area.
Current (past 30 day) suicidal ideation/plan, or recent (past six months) suicidal ideation or suicide attempt.
Active, uncontrolled severe mental illness (e.g. psychosis, bipolar I disorder, schizoaffective disorder – addressed in routine admissions protocol) and/or a history or evidence of organic brain disease or dementia that would compromise the participant’s ability to comply with the study protocol.
Is not currently a participant in a research study or has been in CTIMP research study in the previous 4 months


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Opiate dependency disorder

Intervention(s)

Trade Name: Suboxone
Product Name: Suboxone
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: BUPRENORPHINE
CAS Number: 52485-79-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 8-
INN or Proposed INN: NALOXONE
CAS Number: 465-65-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
INN or Proposed INN: BUPRENORPHINE
CAS Number: 52485-79-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
INN or Proposed INN: NALOXONE
CAS Number: 465-65-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-

Product Name: Methadone hydrochloride
Pharmaceutical Form: Oral solution
INN or Proposed INN: METHADONE HYDROCHLORIDE
CAS Number: 76-99-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 60-120

Primary Outcome(s)

Secondary Objective: A. Are there identical treatment retention and psychological therapy adherence rates between PBI and TAU arms of the study?
B. Are there identical heroin and cocaine craving, and other clinical functioning response profiles between the PBI and TAU arms?
C. What are the longer-term treatment and addiction recovery outcomes for patients receiving PBI and TAU over 5 years, and can biomarkers of differential clinical response be identified?

Timepoint(s) of evaluation of this end point: Timepoint(s) of evaluation of this end point (max 800 characters)
At weeks 21- 24 after enrollment for urine drug tests and 24 weeks for the EQ5D and AD-SUSD

Main Objective: To determine the clinical and cost effectiveness of a personalised behavioural intervention (PBI) compared to treatment-as-usual (TAU) at achieving heroin and cocaine abstinence and health economic outcomes after 12 weeks of PBI, among initially non-responsive patients enrolled in Opiate Substitution Treatment (methadone [MMT]; Suboxone [SMT] (according to clinical preference) in a specialist NHS addictions treatment centre.

Primary end point(s): At week 24 the proportion of patients who are categorised as responder or non-responder.
Responders report no use of heroin or cocaine during weeks 21-24 and submit no positive urine drug tests during weeks 21-24
Non-responders report use of heroin or cocaine during weeks 21-24 or submit a positive urine drug tests during weeks 21-24
At week 24 week the relative cost-effectiveness of trial treatments using:
EQ5D
AD-SUSD

Secondary Outcome(s)

Secondary end point(s): 1. Treatment retention (i.e. days from first dose of OST to treatment exit or follow-up point using information help by the clinic’s electronic patient journey database).
2. Heroin and cocaine craving via Minnesota Cocaine [and heroin] Craving Scale (MCCS) and other scale ratings
3. An exploratory analysis of moderation and mediation of treatment response will be also undertake using the following measures:
? BPD
? BPAQ-S
? BIS-11
? MoCA
? TOP
? WSAS

Timepoint(s) of evaluation of this end point: after enrollment
1. at 24 weeks
2. weeks 4,8,12,14
3. weeks -10, -6, -3, 0, 4, 8, 12,14

Secondary ID(s)

ARC

Source(s) of Monetary Support

Action on Addiction (UK Charity)

Action on Addiction

Secondary Sponsor(s)

South London and Maudsley NHS Foundation Trust