Employment-Based Reinforcement to Motivate Naltrexone Ingestion and Drug Abstinence in the Treatment of Drug Addiction. - 1
| Status: | Not yet recruiting |
|---|---|
| Conditions: | HIV / AIDS, Psychiatric, Gastrointestinal, Pulmonary |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Contact: | Karly N Diemer, M.A., B.S. |
| Email: | kdiemer@jhmi.edu |
| Phone: | (410)550-6723 |
Employment-Based Addiction Pharmacotherapy
A randomized study is planned over 5 years to evaluate the effectiveness of the Therapeutic
Workplace in promoting naltrexone ingestion and abstinence in unemployed opiate-dependent
injection drug users. Participants will be offered an opioid detoxification and naltrexone
induction. Participants who complete the naltrexone induction will be randomly assigned to
one of three groups. All groups will be invited to work in the Therapeutic Workplace and
prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to
work and earn salary. Work Plus Naltrexone Contingency participants will be required to
ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work
Plus Naltrexone and Abstinence Contingency participants will be required to ingest
naltrexone to work, and will receive a brief pay decrease for missing a dose of naltrexone
or for providing an opiate or cocaine positive urine sample. Work Plus Naltrexone
Prescription participants will be prescribed naltrexone, but will not be required to ingest
it to work. This study will provide a rigorous evaluation of a novel employment-based
intervention, the Therapeutic Workplace, to promote naltrexone ingestion and drug abstinence
in a population of injection drug users who are at considerable risk of spreading or
contracting HIV infection. Hypotheses being tested in this study are: Naltrexone ingestion
will be maintained in the two groups exposed to the employment-based naltrexone treatment
significantly more than the group exposed to usual-care treatment package. Opiate abstinence
will be maintained in the two groups exposed to the employment-based naltrexone treatment
significantly more than the group exposed to usual-care treatment package. Cocaine
abstinence will be increased in the group reinforced for cocaine abstinence significantly
more than the group not exposed to abstinence reinforcement.
Workplace in promoting naltrexone ingestion and abstinence in unemployed opiate-dependent
injection drug users. Participants will be offered an opioid detoxification and naltrexone
induction. Participants who complete the naltrexone induction will be randomly assigned to
one of three groups. All groups will be invited to work in the Therapeutic Workplace and
prescribed naltrexone for 26 weeks. The groups will differ in the contingencies imposed to
work and earn salary. Work Plus Naltrexone Contingency participants will be required to
ingest naltrexone to work, and will receive a brief pay decrease for missing a dose. Work
Plus Naltrexone and Abstinence Contingency participants will be required to ingest
naltrexone to work, and will receive a brief pay decrease for missing a dose of naltrexone
or for providing an opiate or cocaine positive urine sample. Work Plus Naltrexone
Prescription participants will be prescribed naltrexone, but will not be required to ingest
it to work. This study will provide a rigorous evaluation of a novel employment-based
intervention, the Therapeutic Workplace, to promote naltrexone ingestion and drug abstinence
in a population of injection drug users who are at considerable risk of spreading or
contracting HIV infection. Hypotheses being tested in this study are: Naltrexone ingestion
will be maintained in the two groups exposed to the employment-based naltrexone treatment
significantly more than the group exposed to usual-care treatment package. Opiate abstinence
will be maintained in the two groups exposed to the employment-based naltrexone treatment
significantly more than the group exposed to usual-care treatment package. Cocaine
abstinence will be increased in the group reinforced for cocaine abstinence significantly
more than the group not exposed to abstinence reinforcement.
Inclusion Criteria:
- CDU patients will be invited to participate in the study if they: a) self-report
injection drug use; b) have observable injection track marks; c) provide
opiate-positive urine at intake to the CDU; d) provided cocaine-positive urine at
intake to the CDU; e) meet DSM IV criteria for Opiate Dependence; f) are unemployed;
g) are between the ages of 18 and 65 years old; h) are medically approved to take
naltrexone treatment; i) report no interest in methadone treatment; j) live within
reasonable commuting distance to the Therapeutic Workplace (e.g, all Baltimore City
zipcodes and the following Baltimore County zipcodes will be included: 21221, 21220,
21222, 21236, 21237, 21234, 21204, 21212).
Exclusion Criteria:
- Patients will be excluded if they a) have current major axis I disorders (e.g.,
Bipolar Disorder, Schizophrenia, Psychosis NOS, Schizophreniform Disorder,
Schizoaffective Disorder); b) if they are pregnant or breastfeeding; c) if serum
aminotransferases results are over three times normal; d) or if the need for opioids
to treat an identified medical problem is anticipated; e) if physical limitations
would prevent them from working (e.g., has a cast on their hand preventing them from
using fingers to type). In addition, the patients with active tuberculosis are not
kept on the CDU, so those individuals will not participate in this research. These
criteria should maintain sample homogeneity, thereby minimizing the impact of
potential confounding variables while insuring patient safety and ability to provide
informed consent.
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