CompletedPhase 1

Effect of Clonidine on Responses to Imagery Scripts

United States92 participantsStarted 2005-06-14

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age between 18 and 55;
. Evidence of current cocaine and/or heroin use (by self-report) with a minimum lifetime drug-use duration of 1 year and a minimum current drug use of once in the last 30 days;

Exclusion criteria

. Hypersensitivity to clonidine or any component of the formulation
. Schizophrenia or any other DSM-IV psychotic disorder; history of anxiety disorder, panic disorder, bipolar disorder; current Major Depressive Disorder
. Current physical dependence on opioids, cocaine, alcohol, benzodiazepines or other sedative-hypnotic; this is an exclusion criterion because we want to evaluate the ability of clonidine to affect stress- and cue-induced drug craving independent of its effects on drug withdrawal

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Subjective ratings of drug craving and mood

Timeframe: 1 hr

Autonomic response (galvanic skin response [GSR])

Timeframe: 1 hr

Heart rate and blood pressure

Timeframe: 1 hr

Endocrine responses (salivary cortisol and salivary alpha-amylase)

Timeframe: 1 hr

Trial details

NCT IDNCT00318760

SponsorNational Institute on Drug Abuse (NIDA)

Sponsor typeNIH

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Cocaine Abuse trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age between 18 and 55;
. Evidence of current cocaine and/or heroin use (by self-report) with a minimum lifetime drug-use duration of 1 year and a minimum current drug use of once in the last 30 days;

Exclusion criteria

. Hypersensitivity to clonidine or any component of the formulation
. Schizophrenia or any other DSM-IV psychotic disorder; history of anxiety disorder, panic disorder, bipolar disorder; current Major Depressive Disorder
. Current physical dependence on opioids, cocaine, alcohol, benzodiazepines or other sedative-hypnotic; this is an exclusion criterion because we want to evaluate the ability of clonidine to affect stress- and cue-induced drug craving independent of its effects on drug withdrawal