Disulfiram for Cocaine Abuse
Information source: University of Arkansas
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Dependence
Intervention: Disulfiram (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Arkansas Official(s) and/or principal investigator(s): Alison Oliveto, Ph.D., Principal Investigator, Affiliation: University of Arkansas
Summary
This study examines the influence of dopamine beta-hydroxylase enzyme activity on the
clinical efficacy of the novel pharmacotherapy, disulfiram, for treating cocaine dependence
in cocaine-dependent patients, some of whom are opioid dependent and maintained on an
FDA-approved opioid agonist. Cocaine dependence as well as co-morbid cocaine and
opioid-dependence is associated with more public health issues and poorer treatment
prognosis when admitted to methadone maintenance. Yet no effective pharmacotherapies have
been developed to treat cocaine dependence to date. One novel pharmacotherapy, disulfiram,
has shown some promise as a treatment for this disorder in several clinical trials at a dose
of 250 mg/day or more (e. g., Carroll et al., 1998, 2004). This 14-week, randomized, double
blind clinical trial will provide treatment for up to160 cocaine-dependent individuals, aged
18-65 years. Participants who are opioid dependent will be stabilized on methadone
maintenance during the first 2 weeks and baseline cocaine use will be assessed; participants
will be stratified by DBH genotype and randomly assigned to receive disulfiram at either 0,
250, 375 or 500 mg/day. During induction onto methadone for opioid dependent individuals,
participants are administered increasing doses of methadone on a daily basis until
maintenance doses are attained. At the beginning of week 3, participants receive methadone,
if relevant, plus disulfiram or placebo disulfiram according to their randomized
assignments, and are maintained on study medication(s) through week 14. At the end of the
study, participants will undergo detoxification from the opioid agonist, if relevant, and
active/placebo medication over a 4- to 6-week period. All participants receive weekly 1-hour
psychotherapy (Cognitive Behavioral Treatment) with experienced clinicians specifically
trained to deliver the therapy and who will receive ongoing supervision. Participants
undergo a delay discounting session during week 1. The primary outcomes will be retention,
reduction in opioid and cocaine use, as assessed by self-report and confirmed by
thrice-weekly urinalyses, and disulfiram side-effects profile. Secondary outcomes will
include reductions in other illicit drug and alcohol use, and improvements in psychosocial
functioning. The prognostic relevance of genotype at the DBH locus, DβH activity, etc., on
response to disulfiram will be examined.
Clinical Details
Official title: Disulfiram for Cocaine Abuse
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Cocaine Use Over Time
Secondary outcome: Retention
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- current users of cocaine, including having a cocaine-positive urine
- self-reported use of > 7 gm during the preceding 6 months and > 1 time/week in at
least one month preceding study entry
- meet DSM-IV criteria for cocaine dependence
Exclusion Criteria:
- current diagnosis of alcohol dependence
- significant medical conditions such as abnormal liver function
- active hepatitis
- hypertension
- a current cardiac condition or high risk of cardiovascular disease
- seizure disorders
- any another significant underlying medical condition which would contraindicate
disulfiram or methadone treatment
- meeting DSM-IV psychiatric classifications for schizophrenia, bipolar disorder, or
other psychotic disorders
- exhibiting current suicidality or homicidality
- pregnancy
- current use of a prescribed psychotropic medication (e. g., antidepressants,
anxiolytics, antipsychotics, anticonvulsants, etc.) which cannot be discontinued
current use of medications such as anticoagulants, isoniazid, metronidazole,
clotrimazole, and paraldehyde.
Locations and Contacts
University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States
Additional Information
Starting date: April 2007
Last updated: September 6, 2013
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