ew pharmacotherapeutic treatment options for crack-cocaine dependent people in the Netherlands: A double-blind, placebo-controlled randomized feasibility study of sustained release dexamphetamine

Phase 2

Completed

• Conditions: middelen afhankelijkheid; cocaine dependence; cocaine addiction

• Registration Number: NL-OMON39005
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

Study participants will be recruited from the population of patients who already receive (ongoing) heroin-assisted treatment in the designated treatment programs in Amsterdam (2 treatment centers), Rotterdam (1 treatment center) and The Hague (1 treatment center). 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.

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure pertains to cocaine use, and is defined as the<br /><br>total number of days of crack-cocaine use during the 12 weeks study period<br /><br>(range: 0 * 84 days).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary effects of the interventions will be evaluated in terms of additional<br /><br>cocaine use related outcome measures (e.g., longest duration of cocaine<br /><br>abstinence, and the number of days cocaine abstinence as well as the mean<br /><br>proportion of cocaine metabolite-free urine samples in the four weeks preceding<br /><br>the week 12 assessment), cocaine craving, use of other substances<br /><br>(self-report), physical and mental health, social functioning (including<br /><br>criminality), and patient satisfaction.</p><br>