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Effect of Clonidine on Responses to Imagery Scripts

NCT00318760 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2018-04-05

No results posted yet for this study

Summary

Background:

\- Research has shown that clonidine, a drug originally prescribed to treat high blood pressure and some symptoms of opioid withdrawal, can help block stress-induced relapse to heroin and cocaine seeking in rats. However, it does not seem to block cue-induced relapse in rats. Researchers are interested in studying whether clonidine shows the same pattern of effects on stress- and cue-induced cravings for heroin or cocaine in humans.

Objectives:

\- To compare the ability of clonidine to reduce stress- and cue-induced cocaine and heroin craving in drug abusers.

Eligibility:

\- Individuals between 18 and 55 years of age who are current cocaine or heroin users.

Design:

* This study will consist of two visits: a screening visit to determine eligibility and an experimental/script session.
* Before the script session, participants will provide urine and breath samples for testing. Participants will complete questionnaires to measure their current drug craving and days since last use of cocaine or heroin.
* At the start of the script session, participants will receive a dose of clonidine or placebo as directed by the study researchers. Three hours after dosing, participants will be read four scripts (two neutral, one stress-inducing, and one drug-cue-related) with breaks in between each script. After each script, participants will respond to questions about levels of stress and craving.
* Participants will provide saliva samples immediately before and during the script readings, and will also be measured for skin response to the scripts.

Conditions

  • Cocaine Abuse
  • Heroin Abuse

Interventions

DRUG

Clonidine

0.1 or 0.2 mg oral, one dose

DRUG

Placebo

oral capsule 1 dose

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

  • Kenzie Preston, Ph.D. · National Institute on Drug Abuse (NIDA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-14
Completion
2013-08-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00318760 on ClinicalTrials.gov