E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cocaine dependence (according DSM-IV) |
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E.1.1.1 | Medical condition in easily understood language |
addiction to cocaine, in its inhalable form (i.e., crack-cocaine or base-coke) |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009817 |
E.1.2 | Term | Cocaine dependence |
E.1.2 | System Organ Class | 100000004873 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | 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) |
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E.5.2 | Secondary end point(s) |
Secondary, cocaine use related outcome measures are: 1) longest duration of cocaine abstinence; 2) the number of days cocaine abstinence in the four weeks preceding the week 12 assessment 3) the mean proportion of cocaine metabolite-free urine samples in the four weeks preceding the week 12 assessment |
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E.5.2.1 | 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) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |