ew pharmacologic treatment for crack-cocaine addicts in the Netherlands: A randomized feasibility study comparing sustained release dexamphetamine with placebo

• Conditions: cocaine dependence (according DSM-IV); MedDRA version: 17.0Level: LLTClassification code 10009817Term: Cocaine dependenceSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-004024-11-NL
• Lead Sponsor: Academic Psychiatric Center - AMC-UvA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-09
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

To qualify for heroin-assisted treatment, patients must meet a set of well-defined selection criteria pertaining to the situation prior to the start of heroin-assisted treatment, which include that the patient must be at least 25 years old, and have a treatment-resistant heroin dependency, as indicated by (a) a history of heroin dependence (DSM-IV) of at least five years, (b) a minimum dose of 50 mg/day (patients who inhale their heroin) or 60 mg/day (patients who inject their heroin) of methadone for an uninterrupted period of at least 4 weeks in the previous 5 years, (c) a history of regular treatment contacts with the methadone program in the previous 6 months, (d) a history of unsuccessful methadone maintenance treatments, (e) daily or nearly daily use of illicit heroin, and (f) poor physical, mental or social functioning (Van den Brink et al., 2003). It is important to note that these selection criteria for participation in heroin-assisted treatment pertain to the situation prior to the start of heroin-assisted treatment, which for most patients is (far) more than a year ago.

To be eligible for the present study, patients must:
1.be at least 25 years old;
2.be cocaine dependent (DSM-IV) during at least the previous 5 years;
3.use cocaine on a regular basis (i.e., = 8 days) in the previous month;
4.administer their cocaine primarily by means of basing ('crack');
5.have a history of earlier failed treatments aimed at reducing, or abstaining from, cocaine use ('treatment-refractory'). In order to qualify as 'treatment-refractory', the patient must have had at least two earlier treatment episodes targeted at reduction of cocaine use, yet still be cocaine dependent in the previous year, and use cocaine on a regular basis in the previous month;
6.be able and willing to participate in the study treatment and assessments;
7.have provided written informed consent.

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 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded in case of:
1.severe medical (e.g., severe renal or kidney insufficiency/failure, hypertension, glaucoma) or psychiatric problems (e.g., acute psychosis or history of drug-induced psychotic disorder, acute suicidality), which constitute a contraindication for participation;
2.cardiovascular problems (ECG);
3.(desired) pregnancy or continued lactation;
4.anticipated necessity of inpatient treatment (clinical judgement);
5.insufficient command of the Dutch language;
6.current participation in another addiction treatment trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This double-blind, placebo-controlled RCT aims to evaluate, in crack-cocaine dependent patients with comorbid heroin dependence, the response to medically prescribed oral dexamphetamine SR (60 mg/day) as an add-on to heroin-assisted treatment, in terms of cocaine use.;Secondary Objective: Secondary objectives of this trial are to evaluate, the response to medically prescribed oral dexamphetamine SR (60 mg/day) as an add-on to heroin-assisted treatment, in terms of substance use (other than cocaine), (physical, mental and social) health, as well as acceptance, medication compliance, safety, and patient satisfaction.;Primary end point(s): The primary outcome measure pertains to cocaine use, and is defined as the total number of days of crack-cocaine use during the 12 weeks study period.;Timepoint(s) of evaluation of this end point: The primary outcome measure will be assessed after 4, 8, and 12 weeks treatment (by means of the Time-Line Follow-Back method)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary, cocaine use related outcome measures are:<br>1) longest duration of cocaine abstinence;<br>2) the number of days cocaine abstinence in the four weeks preceding the week 12 assessment<br>3) the mean proportion of cocaine metabolite-free urine samples in the four weeks preceding the week 12 assessment;Timepoint(s) of evaluation of this end point: The secondary, cocaine use related outcome measures will be assessed after 4, 8, and 12 weeks treatment (by means of the Time-Line Follow-Back method and urinalysis)