Treatment Study: Reducing Cocaine/Heroin Abuse With SR-Amphetamine and Buprenorphine (ARC)

Cocaine dependence, particularly in combination with heroin dependence, poses serious and
substantial public health, social, and economic problems (e.g., high medical costs, crime,
lost productivity). Cocaine and heroin use disorders often co-occur, and this conjunction is
associated with higher rates of medical and psychiatric problems and worse drug abuse
treatment outcome.

Many medications have been tested, but have failed, for treating cocaine dependence alone or
in cocaine abusers who also use heroin.

This clinical trial will test whether SR-AMP is more effective than placebo for preventing
relapse to cocaine use, using SR-AMP for patients with only cocaine dependence, or in
combination with buprenorphine (for those patients who are also dependent on heroin).

Participants will first be an outpatient and must come to the Jefferson Avenue Research
Program three times per week (e.g. Monday, Wednesday, Friday) to measure drug use and
drug-related symptoms. This phase will last at least 2 weeks.

Next, participants will live on an inpatient research unit for seven (7) consecutive nights.
During the weeklong inpatient stay, in addition to receiving SR-AMP or placebo capsules,
participants will begin counseling treatment to help prepare to avoid relapse after they are
discharged from the inpatient unit.

After the inpatient stay, participants will then be an outpatient and come to the Jefferson
Ave. Research Program daily for eight (8) weeks. Throughout all eight weeks, three urine
samples will be collected each week to assess illicit drug use, and questionnaires related
to drug symptoms and to assess mood and risk behaviors will be given.

Inclusion Criteria:

- Male or non-pregnant and non-lactating females between 18-55 years of age who are
seeking treatment for their drug use.

- Females of childbearing potential are eligible to participate if using an acceptable
method of birth control.

- All participants must be free from any significant clinical abnormalities based on
medical history, physical examination, ECG, and screening laboratory tests.

- Participants must weigh at least 50kg (110lbs).

- Participants must meet DSM-IV criteria for current Cocaine Abuse or Dependence, and
possibly Opioid Dependence, and provide a cocaine positive (and, if opioid dependent,
opioid positive) urine sample.

- Participants will not be excluded if they meet DSM-IV criteria for current Alcohol or
Sedative Abuse (but they will be excluded for current Alcohol or Sedative
Dependence).

- Participants must not be under the influence of alcohol (BAL <.002) and sign informed
consent during screening.

Exclusion Criteria:

- Volunteers will not be eligible for this study if they present with psychiatric
illness, neurological disease, cardiovascular disease, pulmonary disease, systemic
disease, other current substance dependence (except cocaine, heroin or nicotine).

- If they are cognitively impaired, currently being treated for Cocaine or Opioid
Dependence, using prohibited medications, or females who are pregnant, lactating, or
if heterosexually active not using medically approved birth control measures.