Modafinil for Smoked Cocaine Self-Administration

N

New York State Psychiatric Institute

Status and phase

Completed
Phase 2

Conditions

Cocaine Dependence

Treatments

Drug: Cocaine 25 mg
Drug: Cocaine 12 mg
Drug: Modafinil 200 mg
Drug: Modafinil 400 mg
Drug: Modafinil 0 mg
Drug: Cocaine 0 mg
Drug: Cocaine 50 mg

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01778010
5738
R01DA023650 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. The present study investigated the effects of modafinil maintenance on cocaine self-administration by frequent users (4 days/week) under controlled laboratory conditions. During this 48-day double-blind, crossover design study, the effects of modafinil maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were examined in nontreatment seeking cocaine-dependent individuals (n = 8).

Enrollment

8 patients

Sex

All

Ages

21 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Smokes cocaine
  • Has patterns of smoked cocaine use in terms of frequency and amount which parallel or exceed those administered in the study.
  • Age 21-50.
  • Able to give informed consent, and comply with study procedures.
  • Normal body weight Within normal weight range (for appropriate frame) according to 1983 Metropolitan Weight tables -

Exclusion criteria

  • Current seizure disorder, heart disease or a history of serious adverse effects due to cocaine.
  • Dependence on substances (other than cocaine or nicotine) or a history of dependence on alcohol
  • Request for drug treatment
  • Judged to be noncompliant with study protocol.
  • Current use of any psychotropic medication.
  • Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; BUN, creatinine, LFTs > 3x ULN; hematocrit < 34 for women, < 36 for men; pseudocholinesterase deficiency)
  • History of myocardial infarction or ischemia, clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse
  • Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
  • Current parole or probation Self-report during interview -

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

8 participants in 3 patient groups, including a placebo group

Modafinil 0mg + Cocaine 0, 12, 25, 50 mg
Placebo Comparator group
Description:
Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine.
Treatment:
Drug: Cocaine 50 mg
Drug: Cocaine 0 mg
Drug: Modafinil 0 mg
Drug: Cocaine 12 mg
Drug: Cocaine 25 mg
Modafinil 200mg + Cocaine 0, 12, 25, 50 mg
Experimental group
Description:
Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine.
Treatment:
Drug: Cocaine 50 mg
Drug: Cocaine 0 mg
Drug: Modafinil 200 mg
Drug: Cocaine 12 mg
Drug: Cocaine 25 mg
Modafinil 400mg + Cocaine 0, 12, 25, 50 mg
Experimental group
Description:
Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine.
Treatment:
Drug: Cocaine 50 mg
Drug: Cocaine 0 mg
Drug: Modafinil 400 mg
Drug: Cocaine 12 mg
Drug: Cocaine 25 mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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