Mental and Behavioral Disorders Due to Use of Cocaine: Harmful UseNCT03278496
Recovery Housing and Drug Abuse Treatment Outcome
A study testing Recovery Housing plus Counseling and Recovery Housing Only in people with Mental and Behavioral Disorders Due to Use of Cocaine: Harmful Use and Opiate Addiction, run by Johns Hopkins University at 1 site in United States.
Trial summary
Reinforcement-Based Therapy (RBT) is an intensive outpatient substance abuse treatment that includes relapse prevention skills training, goal setting, help with finding employment and abstinence-contingent rent payment for recovery housing in the community. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Mental and Behavioral Disorders Due to Use of Cocaine: Harmful Use, Opiate Addiction
- What is being tested?
- Recovery Housing plus Counseling and Recovery Housing Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- completes residential detoxification for use of opiates and/or cocaine
- willing to go to outpatient aftercare
- agrees to random assignment; signs informed consent
Who cannot join
- moving out of town
- primary substance use does not include opiates or cocaine
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavioral Pharmacology Research Unit
Baltimore, Maryland, 21224
About this study
Reinforcement-Based Therapy (RBT) is an intensive outpatient substance abuse treatment that includes relapse prevention skills training, goal setting, help with finding employment and abstinence-contingent rent payment for recovery housing in the community. It is meant to provide motivation for continued abstinence while enhancing social stability. In this study, treatment was offered to inner city opiate and cocaine users immediately following a brief medically-supported residential detoxification. Previous research had shown that RBT produces 3- month outcomes superior to those for patients who are referred to outpatient treatment in the community. The present study compared outcomes for patients (N = 243) randomly assigned to receive abstinence-contingent recovery housing with (full RBT) or without additional intensive counseling or to receive usual care referral to outpatient treatment following detoxification. Outcomes were similar at 3- and 6-month follow-ups for those who received recovery housing with (full RBT) and without additional counseling and both these treatments were superior to usual care referral. Study findings support the efficacy of post-detoxification recovery housing with or without counseling for opiate and cocaine users.
Read the detailed description
Aims To conduct a randomized, controlled trial of abstinence-contingent recovery housing delivered with or without intensive day treatment among individuals exiting residential opioid detoxification.
Design Random assignment to one of three conditions: recovery housing alone (RH), abstinence-contingent recovery housing with reinforcement-based treatment RBT (RH + RBT) or usual care (UC). RH and RH + RBT participants received 12 weeks of paid recovery housing contingent upon drug abstinence. RH + RBT participants also received 26 weeks of RBT, initiated concurrently with recovery housing. Assessments were conducted at 1, 3 and 6 months after treatment enrollment.
Setting Out-patient drug-free substance abuse treatment program in Baltimore, Maryland.
Participants Patients (n = 243) who completed medication-assisted opioid detoxification.
Measurements Primary outcome was drug abstinence (opioid- and cocaine-negative urine and no self-reported opioid or cocaine use in the previous 30 days). Secondary outcomes included abstinence at all time-points (1, 3 and 6 months), days in recovery housing and employment.
- Being tested
- Recovery Housing plus Counseling, Usual Care Referral, Recovery Housing Only
- Keywords
- addiction, substance abuse treatment, aftercare, outpatient counseling, opiates, cocaine
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery Housing plus CounselingBehavioural
Participants receive 3 months of abstinence-contingent program-supported rent payment in community recovery housing. They also receive intensive outpatient counseling (both individual and group) focused on relapse prevention skills training, goal setting, employment seeking and recreational activities.
Usual Care ReferralBehavioural
Participants are referred to an outpatient program of their choosing with an appointment made for them.
Recovery Housing OnlyBehavioural
Participant may receive up to 3 months of abstinence-contingent rent payment in community recovery housing but is not invited to participate in intensive counseling.
| Study group | Role | What they receive |
|---|---|---|
| Recovery housing plus counseling | Experimental | Intensive counseling in a 5-day per week program plus abstinence-contingent rent payment in a community recovery house. Intervention lasts 12 weeks with follow-up at 12 and 24 weeks post treatment entry. Receives: Behavioral: Recovery Housing plus Counseling |
| Recovery Housing only | Experimental | Abstinence-contingent payment for recovery housing rent in absence of any formal counseling. Intervention lasts 12 weeks with follow-up at 12 and 24 weeks post treatment entry. Receives: Behavioral: Recovery Housing Only |
| Usual Care Referral | Active comparator | Participants receive referral resources for community substance abuse counseling and recovery housing but no formal treatment or help with rent payments. All participate in follow-up data collection. Receives: Behavioral: Usual Care Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
abstinence from opiates and cocaine
Free in the community plus self report of no drug use in past 30 days verified with negative urine screen.
Measured: 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study startApr 2001
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental and Behavioral Disorders Due to Use of Cocaine: Harmful UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxine Stitzer, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278496
- Sponsor's protocol ID
- DA13003
- Status last verified
- Sep 2017
- First submitted
- 28 Mar 2014
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tuten M, DeFulio A, Jones HE, Stitzer M. Abstinence-contingent recovery housing and reinforcement-based treatment following opioid detoxification. Addiction. 2012 May;107(5):973-82. doi: 10.1111/j.1360-0443.2011.03750.x. Epub 2012 Feb 28.
PubMed 22151478
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery Housing and Drug Abuse Treatment Outcome
- ClinicalTrials.gov ID
- NCT03278496
- Acronym / sponsor ID
- DA13003
- Keywords
- addiction, substance abuse treatment, aftercare, outpatient counseling, opiates, cocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2001
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reinforcement-Based Therapy (RBT) is an intensive outpatient substance abuse treatment that includes relapse prevention skills training, goal setting, help with finding employment and abstinence-contingent rent payment for recovery housing in the community. It is meant to provide motivation for continued abstinence while enhancing social stability. In this study, treatment was offered to inner city opiate and cocaine users immediately following a brief medically-supported residential detoxification. Previous research had shown that RBT produces 3- month outcomes superior to those for patients who are referred to outpatient treatment in the community. The present study compared outcomes for patients (N = 243) randomly assigned to receive abstinence-contingent recovery housing with (full RBT) or without additional intensive counseling or to receive usual care referral to outpatient treatment following detoxification. Outcomes were similar at 3- and 6-month follow-ups for those who received recovery housing with (full RBT) and without additional counseling and both these treatments were superior to usual care referral. Study findings support the efficacy of post-detoxification recovery housing with or without counseling for opiate and cocaine users.
Detailed description
Aims To conduct a randomized, controlled trial of abstinence-contingent recovery housing delivered with or without intensive day treatment among individuals exiting residential opioid detoxification.
Design Random assignment to one of three conditions: recovery housing alone (RH), abstinence-contingent recovery housing with reinforcement-based treatment RBT (RH + RBT) or usual care (UC). RH and RH + RBT participants received 12 weeks of paid recovery housing contingent upon drug abstinence. RH + RBT participants also received 26 weeks of RBT, initiated concurrently with recovery housing. Assessments were conducted at 1, 3 and 6 months after treatment enrollment.
Setting Out-patient drug-free substance abuse treatment program in Baltimore, Maryland.
Participants Patients (n = 243) who completed medication-assisted opioid detoxification.
Measurements Primary outcome was drug abstinence (opioid- and cocaine-negative urine and no self-reported opioid or cocaine use in the previous 30 days). Secondary outcomes included abstinence at all time-points (1, 3 and 6 months), days in recovery housing and employment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recovery housing plus counseling | Experimental | Behavioral: Recovery Housing plus CounselingIntensive counseling in a 5-day per week program plus abstinence-contingent rent payment in a community recovery house. Intervention lasts 12 weeks with follow-up at 12 and 24 weeks post treatment entry. |
| Recovery Housing only | Experimental | Behavioral: Recovery Housing OnlyAbstinence-contingent payment for recovery housing rent in absence of any formal counseling. Intervention lasts 12 weeks with follow-up at 12 and 24 weeks post treatment entry. |
| Usual Care Referral | Active comparator | Behavioral: Usual Care ReferralParticipants receive referral resources for community substance abuse counseling and recovery housing but no formal treatment or help with rent payments. All participate in follow-up data collection. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- completes residential detoxification for use of opiates and/or cocaine
- willing to go to outpatient aftercare
- agrees to random assignment; signs informed consent
Key exclusion criteria (2 listed)
- moving out of town
- primary substance use does not include opiates or cocaine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recovery Housing plus CounselingParticipants receive 3 months of abstinence-contingent program-supported rent payment in community recovery housing. They also receive intensive outpatient counseling (both individual and group) focused on relapse prevention skills training, goal setting, employment seeking and recreational activities. | Behavioural | Recovery housing plus counseling |
| Usual Care ReferralParticipants are referred to an outpatient program of their choosing with an appointment made for them. | Behavioural | Usual Care Referral |
| Recovery Housing OnlyParticipant may receive up to 3 months of abstinence-contingent rent payment in community recovery housing but is not invited to participate in intensive counseling. | Behavioural | Recovery Housing only |
Primary outcome
abstinence from opiates and cocaine
Time frame: 6 months post randomization
Free in the community plus self report of no drug use in past 30 days verified with negative urine screen.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Results publication: PubMed 22151478Tuten M, DeFulio A, Jones HE, Stitzer M. Abstinence-contingent recovery housing and reinforcement-based treatment following opioid detoxification. Addiction. 2012 May;107(5):973-82. doi: 10.1111/j.1360-0443.2011.03750.x. Epub 2012 Feb 28.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxine Stitzer, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Housing plus Counseling and Recovery Housing Only in people with Mental and Behavioral Disorders Due to Use of Cocaine: Harmful Use and Opiate Addiction, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abstinence from opiates and cocaine (time frame: 6 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03278496, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.