ew pharmacotherapeutic treatment options for crack-cocaine dependent people in the Netherlands.

• Conditions: Crack-cocaine dependence (according to DSM-IV); MedDRA version: 9.1Level: LLTClassification code 10001995Term: Amphetamine and other psychostimulant dependence; MedDRA version: 9.1Level: LLTClassification code 10001996Term: Amphetamine and other psychostimulant dependence, continuous use; MedDRA version: 9.1Level: LLTClassification code 10001997Term: Amphetamine and other psychostimulant dependence, episodic use

• Registration Number: EUCTR2009-010584-16-NL
• Lead Sponsor: ZonMw

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-15
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

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

Inclusion Criteria

(a) at least 18 years old
(b) cocaine dependence (DSM-IV) during at least the previous year
(c) cocaine use on a regular basis (i.e., = 8 days) in the previous month
(d) administer cocaine primarily by means of basing ('crack')
(e) able and willing to participate in outpatient psycho-social treatment and associated assessments (control condition), or be able and willing to participate in outpatient psycho-social treatment supplemented with the study medication and associated assessments (experimental condition)
(f) have provided written informed consent with regard to their assigned study treatment
In the sub-study with dexamphetamine SR, the minimal duration of cocaine dependency will be five years instead of one year. In addition, patients have to meet one extra inclusion criterion: (g) a history of earlier failed treatments aimed at reducing, or abstaining from, cocaine use ('treatment-refractory').
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(a) severe medical (e.g., severe renal or kidney insufficiency/failure) or psychiatric problems (e.g. acute psychosis, current major depression, suicidal) as well as comorbid heroin dependence, which constitute a contra-indication for participation
(b) cardiovascular problems (ECG)
(c) pregnancy or continued lactation
(d) indication for treatment with naltrexone, disulfiram, or acamprosate
(e) anticipated necessity of residential treatment (clinical judgement)
(f) insufficient command of the Dutch language
(g) current participation in another addiction treatment trial

Study & Design

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