Clonidine for Prevention of Relapse to Opiate Abuse

Condition(s) targeted: Opioid-Related Disorders

Intervention: Clonidine (Drug); placebo (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Kenzie L Preston, PhD, Principal Investigator, Affiliation: NIDA Intramural Research Program

Overall contact:
Kenzie L Preston, PhD, Phone: 410-550-1639, Email: kpreston@intra.nida.nih.gov

The purpose of the study is to determine whether clonidine, given to abstinent patients maintainedon buprenorphine, prevents relapse to opioid use more effectively than placebo.

Official title: Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Primary outcome: Opiate-negative urine screens

Secondary outcome:

HIV risk behaviors

craving

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- physical dependence on illicit opioids

- seeking treatment for opioid dependence

- able to attend clinic 7 days/week

Exclusion Criteria:

- any medical or psychiatric condition that would compromise participation in the study

or contraindicate administration of clonidine or buprenorphine

- pregnancy or breast feeding

- cognitive impairment that would cause inability to give informed consent

- allergy or intolerance to buprenorphine or clonidine

- currently taking any medications that are contraindicated with clonidine or

buprenorphine

Kenzie L Preston, PhD, Phone: 410-550-1639, Email: kpreston@intra.nida.nih.gov

NIDA Intramural Research Program, Baltimore, Maryland 21224, United States; Recruiting

Starting date: September 2006
Ending date: September 2010
Last updated: June 19, 2008