Effect of Clonidine on Responses to Imagery Scripts
|ClinicalTrials.gov Identifier: NCT00318760|
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : July 2, 2017
|First Submitted Date ICMJE||April 25, 2006|
|First Posted Date ICMJE||April 27, 2006|
|Last Update Posted Date||July 2, 2017|
|Start Date ICMJE||June 14, 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00318760 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effect of Clonidine on Responses to Imagery Scripts|
|Official Title ICMJE||Effect of Clonidine on Responses to Imagery Scripts|
- 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.
- To compare the ability of clonidine to reduce stress- and cue-induced cocaine and heroin craving in drug abusers.
- Individuals between 18 and 55 years of age who are current cocaine or heroin users.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Enrollment ICMJE||160|
|Completion Date||August 7, 2013|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Women who do not agree to use these medically effective forms of contraception while in the study will be excluded.
|Ages||18 Years to 55 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00318760|
|Other Study ID Numbers ICMJE||999905403
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute on Drug Abuse (NIDA)|
|Collaborators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 8, 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP