Cocaine Abuse Clinical Trial
Official title:
Effect of Clonidine on Responses to Imagery Scripts
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.
Background. Stress and exposure to drug-related cues (environmental stimuli previously
associated with drug availability) are considered factors that increase the risk of relapse
to heroin and/or cocaine use. The two factors may act through different neural mechanisms.
Alpha-2 adrenergic agonists, such as clonidine, have been shown to block stress-induced
relapse, but not cue-induced relapse, to heroin and cocaine self-administration in rodents.
The ability of clonidine to attenuate stress- or cue-induced heroin and cocaine craving in
drug abusers has not been tested. It is important to determine, in humans, whether clonidine
blocks the acute effects of only one putative class of relapse precipitants, or whether its
effects are more general.
Scientific goal. To compare the ability of clonidine to reduce stress-induced and cue-induced
cocaine and heroin craving in drug abusers.
Participant population. A total of up to 160 drug abusers using cocaine, heroin, or both will
be enrolled. Target enrollment will include 40% women and 60% minorities (mostly
African-American).
Experimental design and methods. Participants will be randomized to one of three groups
receiving clonidine 0.1 mg, clonidine 0.2 mg, or placebo orally under double-blind
conditions. The study will consist of a single 5-6 hr experimental session in which there
will be baseline measures, drug administration, and four script-guided imagery sets, each
followed by a period of data collection. Three hours after dosing (when peak plasma clonidine
concentrations are reached), participants will be exposed to four scripts: one
stress-inducing, one describing drug cues, and two with neutral content. The standardized
script-guided imagery procedure has previously been shown to reliably induce negative
affective states (stress scripts) and/or craving (stress and drug-cue scripts) compared to
the neutral scripts and to have internal and external validity (Tiffany and Drobes, 1990;
Maude-Griffin and Tiffany, 1996; Taylor et al., 2000; Sinha et al., 1999, 2000, 2003;
Singleton et al., 2003; Tiffany and Haekeneworth, 1991; Elash et al., 1995; Drobes and
Tiffany, 1997; Taylor et al., 2000; Singleton et al., 2003). Outcome measures will include
subjective ratings of drug craving and mood, autonomic response (galvanic skin response
[GSR]), and endocrine responses (salivary cortisol and salivary ?-amylase, a measure of
endogenous adrenergic activity during stress (Chatterton et al., 1996; Nater et al., 2005;
van Stegeren et al., 2005)).
Benefits to participants and/or society. There are no direct benefits to participants.
However, if clonidine is effective in blocking stress-induced and/or cue-induced craving,
then the results will be used as a basis for designing a treatment trial, and drug abusers
and society may benefit from the eventual use of clonidine or other alpha agonists for
prevention of relapse in cocaine and heroin users. In addition, this research will provide
information on the clinical relevance of a preclinical model of relapse, possibly
strengthening arguments for its use in medication development.
Risks to participants. Participants may experience side effects from clonidine such as
sedation and are expected to experience brief, mild psychological stress and drug craving
from the laboratory script procedures. Prior to leaving the session, participants will be
assessed for the presence of continued drug effects. If participants are experiencing any
stress or craving at the end of the session, they will undergo a 10-minute guided relaxation
session, which will be repeated until feelings of stress or craving dissipate, before being
released from the laboratory. Participants may be kept longer than the planned session
length, up to and including staying overnight on the inpatient ward, because of continued
side effects or elevated stress or craving. If the MRP deems it medically necessary,
participants will be sent to JHBMC emergency department for further evaluation and treatment.
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