Clonidine for Relapse Prevention in Buprenorphine-Maintenance Patients

NCT00295308 | Completed Phase 1

• 2 other identifiers: 99990640706-DA-N407
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

Background:

• Though the drug buprenorphine effectively treats dependence on opioids like heroin, some abstinent patients relapse to use during treatment. This relapse may be triggered by stress or stressful situations, and buprenorphine probably has no specific protective effect in these situations. Buprenorphine probably also has no specific effect on relapse to cocaine use.
• 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. Researchers are interested in studying whether a combination of clonidine and buprenorphine may be more effective in preventing drug relapse than administering one of the medications alone. Objectives: \- To determine whether clonidine, given to abstinent patients maintained on buprenorphine, is more effective than placebo in preventing relapse to heroin or cocaine use. Eligibility: \- Individuals between 18 and 50 years of age who are current cocaine or heroin users seeking treatment. Design:
• The study will last up to 36 weeks, with four phases of treatment and a follow-up evaluation. Three times a week, participants will be asked to report illicit drug use and provide urine and breath samples. Throughout the study, participants will receive individual counseling in weekly 40 60 minute sessions. Other samples and tests will be scheduled as required by the study researchers.
• Patients will be stabilized on daily buprenorphine over the first 14 days of the study.
• Weeks 1 8: Participants will receive vouchers for regular substance-free urine samples. Those who successfully complete this phase will continue to the next part of the study.
• Weeks 7 9: Participants will receive either clonidine or placebo along with the buprenorphine. The dose of clonidine will be stabilized during this time.
• Weeks 9 22: Participants will continue to receive either clonidine or placebo along with the buprenorphine. During this part of the study, participants will keep electronic diaries to record drug use or craving and to record data on mood, stress levels, and activity.
• Weeks 23 28: Participants will stop taking the clonidine or placebo, but will continue the buprenorphine treatment. Participants will continue to keep electronic diaries.
• Weeks 29 36: Participants will have the choice of transferring to a community clinic transfer or gradually reducing doses of buprenorphine to end the study.
• Participants will return for a follow-up visit and urine sample 6 months after the end of the study.

Conditions

Opioid-Related Disorders

Keywords

Opioid Dependence; Clonidine; Buprenorphine; Opioid Abstinence; Relapse

Outcome Measures

Primary Outcomes (1)

• Opiate-negative urine screens

  38 weeks

Secondary Outcomes (2)

• HIV risk behaviors

  38 weeks

• Craving

  18 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Clonidine

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Clonidine DRUG

clonidine up to 0.3 mg/day oral

Arm 1

Placebo DRUG

oral capsules daily

Arm 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 60
• Evidence of physical dependence on opioids (self-report, urine screen, physical exam)
• Seeking treatment for opioid dependence
• Able to attend treatment clinic 7 days/week

You may not qualify if:

• General-
• Poor venous access
• Urologic conditions that would inhibit urine collection
• Pregnancy or breastfeeding
• Failure to agree to use a medically effective form of contraception while in the study (in women who are sexually active with a male partner and able to get pregnant). Acceptable forms of contraception for this study include: hormonal contraceptives (birth control pills, injectable hormones, vaginal ring hormones), surgical sterility (tubal ligation or hysterectomy); IUD; Diaphragm with spermicide; Condom with spermicide
• Current physical dependence on alcohol or sedative-hypnotics, e.g. benzodiazepines
• Psychiatric-
• Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires (Shipley Institute of Living scale estimated full-scale IQ less than 80)
• History of schizophrenia or any other DSM-IV psychotic disorder
• History of bipolar disorder
• Current Major Depressive Disorder
• Medical-
• Any active or untreated medical illness that in the view of the investigators would compromise participation in research
• Allergy or intolerance to either buprenorphine or clonidine
• Cerebrovascular disease

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 (2)

• Kowalczyk WJ, Moran LM, Bertz JW, Phillips KA, Ghitza UE, Vahabzadeh M, Lin JL, Epstein DH, Preston KL. Using ecological momentary assessment to examine the relationship between craving and affect with opioid use in a clinical trial of clonidine as an adjunct medication to buprenorphine treatment. Am J Drug Alcohol Abuse. 2018;44(5):502-511. doi: 10.1080/00952990.2018.1454933. Epub 2018 Apr 10.

  PMID: 29634425 DERIVED

• Kowalczyk WJ, Phillips KA, Jobes ML, Kennedy AP, Ghitza UE, Agage DA, Schmittner JP, Epstein DH, Preston KL. Clonidine Maintenance Prolongs Opioid Abstinence and Decouples Stress From Craving in Daily Life: A Randomized Controlled Trial With Ecological Momentary Assessment. Am J Psychiatry. 2015 Aug 1;172(8):760-7. doi: 10.1176/appi.ajp.2014.14081014. Epub 2015 Mar 17.

  PMID: 25783757 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Recurrence

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental 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: February 22, 2006
• First Posted: February 23, 2006
• Study Start: November 8, 2005
• Study Completion: July 30, 2014
• Last Updated: December 17, 2019

Record last verified: 2014-09-17

Locations

US (1)