Clinical trial NCT01003496: Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial
Official title: Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Drug Addiction
Keywords: Cocaine
crack
heroin
non-prescribed opioids
contingency management
community reinforcement approach
facilitated therapeutic alliance
chronic disease treatment models
Lead sponsor: Wright State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Maryhaven
name: University of Arkansas
First posted: 2009-10-28
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this 2 year study is to conduct a fully powered effectiveness trial comparing recovery trajectories of 200 drug dependent adults (the subjects) who will be randomly assigned to Treatment as Usual (TAU) or TAU + Long-Term Recovery Management (LTRM).

Detailed description: Drug addiction is a chronic illness characterized by problematic drug use, followed by periods of abstinence, reductions in use, or return to problematic drug use. Despite this, substance abuse treatment has traditionally been based on an acute care model. The field needs an addiction management model for drug-dependent patients, which, like disease management for other chronic conditions, provides: 1) initial stabilization; 2) ongoing treatment to maintain clinical gains; 3) monitoring of patient symptoms; and 4) adjustments to the treatment based on the patient's response.

In response to these needs we have developed the Long Term Recovery Management (LTRM) model. LTRM is predicated on initiating long-term addiction management at the onset of substance abuse treatment, extending the length of treatment, expediting the transitions between intensive treatment and maintenance of behavioral change, adapting treatment intensity to patient's response to treatment, and actively facilitating the therapeutic alliance. LTRM combines 3 established treatment techniques (Community Reinforcement Approach, Contingency Management, and Facilitated Therapeutic Alliance), each with demonstrated efficacy, into a chronic disease model. In addition, patient cases are kept open, thereby removing potential obstacles to re-engagement with stepped-up care, when indicated. The LTRM model emphasizes: engagement in continuous long-term treatment and recovery support, therapeutic alliance, and early re-intervention as the main mechanisms for maintenance of behavioral change.

Eligibility criteria: Inclusion Criteria:

To be eligible for the study, a subject must:

* At least 18 years of age
* Meet current dependence criteria for stimulants (cocaine/other), opioids (heroin/other), and/or alcohol (if also dependent on cocaine or opioids). Persons who are opioid dependent are eligible if they are not in methadone maintenance therapy; they will be eligible if they are in short-term buprenorphine detoxification
* Self-report use of a primary drug of dependence in the past 60 days; 4) be admitted to outpatient care at Maryhaven
* Willing to participate in the protocol (i.e., to be randomized to treatment condition and agree to attend regular treatment sessions).

Exclusion Criteria:

* Potential subjects will be excluded if they: 1) present with current suicide risk
* Have a current, untreated psychotic disorder
* Plan to relocate outside of the area within 12 months
* Have been sentenced to incarceration of more than 30 days over the next 6 months
* Are alcohol dependent without current dependence on cocaine or opioids.

Primary outcomes:
measure: The main outcome is weeks of abstinence from the primary drug of dependence.
timeFrame: 12 months
Secondary outcomes:
measure: Secondary outcomes include drug-free days and reduction in HIV risk behaviors.
timeFrame: 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Maryhaven
state: Ohio
Study officials:
affiliation: Wright State University Boonshoft School of Medicine
name: Robert G Carlson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wright State University Boonshoft School of Medicine
name: Russel Falck, MA
role: STUDY_DIRECTOR
affiliation: Maryhaven
name: Gregory Brigham, Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Arkansas
name: Brenda M Booth, Ph.D.
role: STUDY_DIRECTOR
References: