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Infusion Laboratory: Protocol 1 - Selegeline - 2

Primary Purpose

Cocaine-Related Disorders

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Selegiline

About this trial

This is an interventional treatment trial for Cocaine-Related Disorders focused on measuring cocaine dependence

Eligibility Criteria

31 Years - 47 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: M/F, ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe.

Sites / Locations

Friends Research Institute

Outcomes

Primary Outcome Measures

Degree of drug craving

History, incidence and amount of drug use

Type and severity of stimulant withdrawal symptoms

Population incidence of symptoms of depression, possible organic brain syndrome deficits

Frequency and intensity of drug use and sexual behaviors at risk for HIV

Evidence of change in neurophysiology and brain activity

Evidence of change in subjective responses to cocaine challenge

Clinical physiological response to cocaine challenge - especially adverse effects measures

Degree to which study medication influences changes in #6, 7 & 8 above (possible efficacy measure)

Characterization of study population

Secondary Outcome Measures

Full Information

NCT ID

NCT00000337

First Posted

September 20, 1999

Last Updated

January 11, 2017

Sponsor

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00000337

Brief Title

Infusion Laboratory: Protocol 1 - Selegeline - 2

Official Title

Infusion Laboratory: Protocol 1 - Selegeline

Study Type

Interventional

2. Study Status

Record Verification Date

August 1996

Overall Recruitment Status

Completed

Study Start Date

November 1994 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to determine the effects of selegiline on the subjective and physiological effects of cocaine challenge in chronic crack abusers, and to evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.

Detailed Description

To develop a medication for the treatment of cocaine addiction using a medical human physio-neuro-psycho-immunology laboratory setting. To characterize this cocaine abusing population on a variety of psychological and physicologically measures over time from withdrawal through pere and post cocaine administration. To determine the effects of selegeline on the subjective and physiological effects of cocaine challenge in chronic crack abusers. To evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine-Related Disorders

Keywords

cocaine dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

0 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Selegiline

Primary Outcome Measure Information:

Title

Degree of drug craving

Title

History, incidence and amount of drug use

Title

Type and severity of stimulant withdrawal symptoms

Title

Population incidence of symptoms of depression, possible organic brain syndrome deficits

Title

Frequency and intensity of drug use and sexual behaviors at risk for HIV

Title

Evidence of change in neurophysiology and brain activity

Title

Evidence of change in subjective responses to cocaine challenge

Title

Clinical physiological response to cocaine challenge - especially adverse effects measures

Title

Degree to which study medication influences changes in #6, 7 & 8 above (possible efficacy measure)

Title

Characterization of study population

10. Eligibility

Sex

All

Minimum Age & Unit of Time

31 Years

Maximum Age & Unit of Time

47 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Walter Ling, M.D.

Organizational Affiliation

Friends Research Institute, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Friends Research Institute

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

12. IPD Sharing Statement

Citations:

Citation

1996 CPDD: "Acute cocaine administration reverses EEG signs of cocaine withdrawal.". 1996 CPDD: "Acute cocaine administration reverses EEG signs of cocaine withdrawal."

Results Reference

background

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Infusion Laboratory: Protocol 1 - Selegeline - 2

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