Effect of Clonidine on Responses to Imagery Scripts

NCT00318760 | Completed Phase 1

• 2 other identifiers: 99990540305-DA-N403
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Drug Cue; Relapse; Stress; Craving

Outcome Measures

Primary Outcomes (4)

• Subjective ratings of drug craving and mood

  1 hr

• Autonomic response (galvanic skin response [GSR])

  1 hr

• Heart rate and blood pressure

  1 hr

• Endocrine responses (salivary cortisol and salivary alpha-amylase)

  1 hr

Study Arms (2)

ARM 1

EXPERIMENTAL

Drug: Clonidine

ARM 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Clonidine DRUG

0.1 or 0.2 mg oral, one dose

ARM 1

Placebo DRUG

oral capsule 1 dose

ARM 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

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• 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
• Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires
• Pregnancy or breast feeding
• Severely impaired hepatic function
• Severely impaired renal function, with CLcr \< 10 ml/minute
• Medical conditions that contraindicate or that could complicate clonidine administration:
• hypotension (SBP \<95 or DBP \< 40 mm Hg) over several readings
• hypertension(SBP \>160 mm Hg, DBP \>95 mm Hg) over several readings
• orthostatic hypotension over several readings or as a consequence of any underlying medical disorder (e.g., autonomic insufficiency)
• bradycardia (heart rate \< 50 bpm) over several readings
• cerebrovascular disease or any history of CVA or transient ischemic attack (TIA)
• documented coronary disease
• serious arrhythmia or conduction defect (e.g., second or third degree heart block, atrial fibrillation)

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• Abduljawad KA, Langley RW, Bradshaw CM, Szabadi E. Effects of clonidine and diazepam on the acoustic startle response and on its inhibition by 'prepulses' in man. J Psychopharmacol. 1997;11(1):29-34. doi: 10.1177/026988119701100110.

  PMID: 9097890 BACKGROUND

• Benschop RJ, Jacobs R, Sommer B, Schurmeyer TH, Raab JR, Schmidt RE, Schedlowski M. Modulation of the immunologic response to acute stress in humans by beta-blockade or benzodiazepines. FASEB J. 1996 Mar;10(4):517-24. doi: 10.1096/fasebj.10.4.8647351.

  PMID: 8647351 BACKGROUND

• Berger SP, Hall S, Mickalian JD, Reid MS, Crawford CA, Delucchi K, Carr K, Hall S. Haloperidol antagonism of cue-elicited cocaine craving. Lancet. 1996 Feb 24;347(9000):504-8. doi: 10.1016/s0140-6736(96)91139-3.

  PMID: 8596268 BACKGROUND

MeSH Terms

Conditions

Cocaine-Related Disorders; Heroin Dependence; Recurrence

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kenzie Preston, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 25, 2006
• First Posted: April 27, 2006
• Study Start: June 14, 2005
• Study Completion: August 7, 2013
• Last Updated: April 5, 2018

Record last verified: 2014-07-08

Locations

US (1)