Sustained Release d-Amphetamine & Buprenorphine on Drug Seeking Behavior in Opioid & Cocaine Dependent Individuals
Information source: Wayne State University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heroin Dependence; Opioid-Related Disorders; Cocaine Abuse or Dependence
Phase: Phase 1
Status: Completed
Sponsored by: Wayne State University Official(s) and/or principal investigator(s): Mark Greenwald, PhD, Principal Investigator, Affiliation: Wayne State University
Summary
The purpose of this study is to determine whether maintenance on different oral doses of
sustained release d-amphetamine (SR-AMP) combined with constant-dose sublingual
buprenorphine (BUP) is safe and well tolerated and decreases self-administration of cocaine
alone or combined with hydromorphone (HYD). Secondary aims are to determine whether SR-AMP
attenuates the subjective and physiological effects of cocaine during drug sampling periods
prior to choice opportunities.
Clinical Details
Official title: Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine: Study 1
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Detailed description:
Heroin abusers also frequently abuse cocaine, and concurrent use of these drugs is
associated with more severe drug dependence and associated psychiatric and medical problems,
greater risk for HIV infection, worse drug abuse treatment outcome, and creates a public
health burden. New methods and solutions are needed for this problem.
While human laboratory models exist to study choice of cocaine or opioids individually,
studies have not examined choice of cocaine alone or cocaine/opioid combinations by heroin
dependent individuals, nor have there been interventions to reduce such drug use. We
recently developed a sensitive laboratory-based choice progressive ratio procedure to study
drug-seeking behavior for opioids. This study will extend this procedure, in the form of
drug combination vs. money choices, to obtain a novel human laboratory model of
cocaine/opioid abuse. The purpose of this study is to determine whether maintenance on
different doses of sustained release d-amphetamine (SR-AMP) combined with constant-dose
buprenorphine (BUP) is safe and well tolerated and decreases self-administration of cocaine
alone or combined with HYD. Secondary aims are to determine whether SR-AMP attenuates the
subjective and physiological effects of cocaine during drug sampling periods prior to choice
opportunities.
One goal of this new study is to develop a human laboratory model of polydrug abuse by
allowing participants (who abuse both heroin and cocaine) to choose between drug
combinations or money. The second goal of this study is to develop medication treatments to
reduce cocaine use by opioid dependent individuals.
Participants in this observational study will take part in multiple trials in which they
have the opportunity to choose between drug combinations (cocaine alone or combined with
HYD; relative to HYD alone and dual placebo) or money. On the morning of each session,
prior to the choice procedure, participants will receive a sample of the drug dose that can
be chosen. Participants will be asked to attend to the effects produced by the drug
combination because they will be able to choose this relative to money in the choice task in
the afternoon session. During the choice procedure, participants will have 12 opportunities
to choose either drug or money. Participants will use a computer to earn choices.
Respiration rate, oxygen saturation, heart rate, and blood pressure will be monitored
throughout the study. Self-report questionnaires will be completed at different times
during the study. Participants will be maintained on a constant dose of BUP throughout the
study, with a minimum 2-week lead before the experiment, and a fixed 3-week detoxification
after study completion. During the experiment they will be maintained on different doses of
SR-AMP and on a constant dose of BUP.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Opioid dependent and Cocaine abuse or dependence, as determined by structured
clinical interview for DSM-IV (SCID) and Addiction Severity Index (ASI)
- Positive urine test for opiates and cocaine
- Willing to use an adequate form of contraception for the duration of the study
- Reads and writes English
Exclusion Criteria:
- Psychiatric illness, as determined by the DSM-IV criteria
- History of, or current neurological disease, including structural abnormalities,
seizures, infectious disease, history of other neurological diseases or head trauma.
- History of cardiovascular disease, myocardial infarction, chest pain or palpations on
exertion or drug use
- Systolic blood pressure greater than 160 or less than 95 mmHg; Diastolic blood
pressure >95 mmHg
- Clinically abnormal ECG
- Pulmonary disease, including asthma, obstructive pulmonary disease, cor pulmonale,
tuberculosis
- Systemic disease (e. g., endocrinopathies, liver or kidney failure, myxedema,
hypothyroidism, Addison's disease, autoimmune disease)
- Current alcohol or sedative drug dependence
- Pregnant or breastfeeding
- Currently receiving treatment for a Substance Abuse/Dependence Disorder or seeking
treatment
- Been in a research study within the last 30 days
- Known phobia of injections
Locations and Contacts
Wayne State University, Detroit, Michigan 48207, United States
Additional Information
Starting date: January 2007
Last updated: June 1, 2012
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