Carvedilol for Psychostimulant Dependence

This study has been completed.
Sponsor:
Collaborators:
Baylor College of Medicine
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01171183
First received: July 27, 2010
Last updated: June 23, 2014
Last verified: June 2014

July 27, 2010
June 23, 2014
August 2010
May 2014   (final data collection date for primary outcome measure)
urine toxicology screens [ Time Frame: thrice weekly for 12 weeks ] [ Designated as safety issue: No ]
cocaine use, as measured by thrice-weekly urine toxicology screens
Same as current
Complete list of historical versions of study NCT01171183 on ClinicalTrials.gov Archive Site
retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
number of weeks each participant is on study protocol
  • retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    number of weeks each participant is on study protocol
  • withdrawal symptoms [ Time Frame: thrice weekly during weeks 1 and 2 ] [ Designated as safety issue: No ]
  • orthostatic blood pressure [ Time Frame: thrice weekly for 15 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Carvedilol for Psychostimulant Dependence
Clinical Efficacy of Carvedilol for Psychostimulant Dependence

This study examines whether carvedilol prolongs abstinence in recently abstinent cocaine dependent participants.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cocaine Dependence
  • Cocaine Withdrawal
  • Drug: controlled release carvedilol
    carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
    Other Name: Coreg CR
  • Drug: Placebo
    Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Carvedilol controlled release
    controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing
    Intervention: Drug: controlled release carvedilol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-45 years old
  • Cocaine dependence, as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV.
  • At least weekly self-reported cocaine use during a preceding three month period
  • Urine toxicology screen positive for cocaine or cocaine metabolite
  • Women of childbearing age must have a negative pregnancy test, agree to adequate contraception to prevent pregnancy during the study, agree to monthly pregnancy testing and not be nursing

Exclusion Criteria:

  • Suicide attempts within the past 12 months or suicidal ideations or psychotic symptoms in the past 6 months as determined by a study physician.
  • Current opioid, alcohol or sedative physical dependence or amphetamine dependence.
  • Major cardiovascular disorder that contraindicates study participation (e.g., history of myocardial infarction, stroke, congestive heart failure, cardiac arrhythmia, significant hypertension [i.e., >170 SBP or >110 DBP] or an unstable medical condition (e.g., untreated bacterial infection) as determined by the study physician.
  • Asthma or chronic obstructive pulmonary disease.
  • History of schizophrenia, or bipolar type I disorder.
  • Use of medications that would be expected to have major interaction with carvedilol (e.g., rifampin, cimetidine, digoxin, diuretics).
  • Medical contraindication to receiving carvedilol (e.g., diabetes, severe bradycardia, bronchial asthma or other bronchospastic condition, 2nd or 3rd degree AV block, sick sinus rhythm, severe hepatic impairment, documented hypersensitivity to carvedilol).
  • Patients currently taking selective serotonin re-uptake inhibitors, antipsychotics and antidepressants (e.g., amitriptyline and imipramine).
  • Liver function tests (i.e., liver enzymes) greater than three times normal levels.
  • Systolic blood pressure > 170 mmHg or < 90 mmHg, diastolic blood pressure > 110 mmHg or < 60 mmHg, or heart rate of > 110 beats/min or < 55 beats/min. Supine blood pressure of 100/65 mm Hg or lower, a seated blood pressure of 90/60 mm Hg or lower, or an orthostatic change of >20mm Hg systolic or 10 mm Hg diastolic on standing.
  • Participants with estimated glomerular filtration rate < 30 ml/min.
  • Pregnant or nursing female.
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01171183
2 P50 DA018197, 2P50DA018197
Yes
University of Arkansas
University of Arkansas
  • National Institute on Drug Abuse (NIDA)
  • Baylor College of Medicine
Not Provided
University of Arkansas
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP