Acute Withdrawal From Smoked Cocaine - 9 - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Collaborator:	University of Minnesota
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00000292

Purpose

The purpose of this study is to develop an experimental paradigm to examine acute withdrawal symptoms from cocaine.

Condition	Intervention	Phase
Cocaine-Related Disorders Substance Withdrawal Syndrome Substance-Related Disorders	Procedure: Cocaine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Double-Blind
Official Title:	Acute Withdrawal From Smoked Cocaine

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Behavioral
Subjective
Physiological measures

Estimated Enrollment:	0
Study Start Date:	April 1996
Estimated Study Completion Date:	December 2001

Detailed Description:

Although there are clearly identifiable withdrawal syndromes following cessation of a number of abused drugs such as alcohol and heroin, it is unclear whether a withdrawal syndrome follows the cessation of crack cocaine. A laboratory model of withdrawal from smoked (crack) cocaine would provide a safe and systematic method of testing the efficacy of behavioral or pharmacological treatments for withdrawal symptoms following cocaine smoking cessation. Therefore, this study investigated acute behavioral, subjective, and physiological withdrawal symptomatology for 6 hrs following 7 deliveries of 2 dose sized (0.07 vs. 0.4 mg/kg) of smoked cocaine. The behavioral measure was performance on a computerized reaction time task, subjective measures included participant and observer ratings of mood and withdrawal symptomatology, and physiological measures comprised heart rate and blood pressure. It was hypothesized that signs and symptoms of withdrawal from smoked cocaine would be greater following the 0.4 mg/kg dose size, compared to the 0.07 mg/kg dose size.

Eligibility

Ages Eligible for Study:	21 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

M/F ages 21-45 with a history of smoked cocaine use at least twice a week for the past six months, including 0.5 g of cocaine in a 24hr period on at least one occasion. In good health as evidenced by physical exam and complete blood count, chest X-ray and electrolyte and liver function tests, with a normal resting 12-lead electrocardiograph (ECG) and blood pressure of less than 140/90 mmHg. Using an acceptable method of birth control. Having a urine toxicology screen positive for cocaine metabolites.

Exclusion Criteria:

Any DSM-IV Axis I disorder other than cocaine abuse or dependence, or dependence or daily use of psychoactive drugs other than nicotine or caffeine. A history of violence and/or currently on probation, parole or awaiting trial. Pregnant as determined by serum pregnancy screen, lactating or having delivered a child in the past 12 months. Seropositive tests for the human immunodeficiency virus (HIV) or hepatitis B. History of seizure disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000292

Locations

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

University of Minnesota

Investigators

Principal Investigator:

Dorothy Hatsukami, Ph.D.

University of Minnesota

More Information

No publications provided

Study ID Numbers:	NIDA-09259-9, P50-09259-9
Study First Received:	September 20, 1999
Last Updated:	November 3, 2005
ClinicalTrials.gov Identifier:	NCT00000292 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Substance Withdrawal Syndrome
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Disorders of Environmental Origin
Anesthetics
Pathologic Processes
Mental Disorders
Sensory System Agents
Therapeutic Uses
Syndrome

Vasoconstrictor Agents
Substance-Related Disorders
Cocaine
Cocaine-Related Disorders
Disease
Central Nervous System Depressants
Cardiovascular Agents
Pharmacologic Actions
Anesthetics, Local
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009