Drug AddictionNCT00744068
Four Models of Telephone Support for Stimulant Recovery
A study testing Continuing Care Telephone Support in people with Drug Addiction, run by University of California, Los Angeles at 6 sites in United States.
Trial summary
The overall objective of this research is to develop and refine empirically supported continuing care interventions that promote healthy behavior and sustained abstinence from illicit drug use. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Drug Addiction
- What is being tested?
- Continuing Care Telephone Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2006to Sep 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, 18-65 years of age.
- Meet DSM-IV criteria (at the time of treatment admission) for cocaine or methamphetamine abuse/dependence.
- Have completed the primary phase of treatment at a Matrix outpatient clinic.
- Have telephone access throughout the study procedures.
- Be able to understand and complete rating scales and to follow instructions.
- Be willing to sign an informed consent form.
Who cannot join
- Have participated in a treatment-related study conducted by the PI and colleagues during the previous 3 years and/or is currently enrolled in a treatment-related study.
- Have any medical, legal, housing or transportation problem which would preclude either safe or consistent participation.
- Have dropped out of the primary phase of treatment prior to completion.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Twin Town Treatment Center
Los Alamitos, California, 90720
Matrix Institute on Addictions
Los Angeles, California, 90025
UCLA Integrated Substance Abuse Programs
Los Angeles, California, 90025
Matrix Institute on Addictions
Rancho Cucamonga, California, 91730
Twin Town Treatment Center
West Hollywood, California, 90069
Matrix Institute on Addicitions
Woodland Hills, California, 91364
About this study
The overall objective of this research is to develop and refine empirically supported continuing care interventions that promote healthy behavior and sustained abstinence from illicit drug use.
Read the detailed description
For treatment interventions to provide the desired result of long term abstinence, it is important to develop strategies to enhance the effectiveness of continued care approaches. We plan to conduct a prospective, randomized comparison of four models of counselor-provided telephone support as strategies to promote patient aftercare attendance and sustained abstinence from stimulant use. To this end, we will develop and compare the efficacy of four low-cost telephone support protocols for patients who have completed the intensive phase of a structured, outpatient stimulant abuse treatment program. Some 500 participants completing a 4-month Matrix Outpatient Model of stimulant abuse treatment will be randomly assigned to one of four counseling groups (n=100 per group): (1) unstructured/non-directive, (2) structured/non-directive, (3) unstructured/directive, or (4) structured/directive telephone counseling, or (5) a control group consisting of standard referral to Matrix aftercare, for a total sample size of 500. The two structured conditions will be based on the behavioral "prompts" identified by Farabee et al. (2002)* as being associated with drug avoidance. In the non-directive conditions, subjects will be allowed to state their own goals and how they intend to achieve them. In the directive conditions, the counselor will provide specific recommendations to help the subject adopt as many of the drug-avoidance activities as possible. Outcomes will be tracked for 12 months following completion of primary treatment (a total of 16 months after treatment admission) and will include measurement of participation in drug-avoidance activities (including aftercare participation) as well as self-reported and objective measures of substance use and related behavior change.
*Farabee, D., Rawson, R.A., \& McCann, M. (2002). Adoption of drug avoidance activities among patients in contingency management and cognitive-behavioral treatments. Journal of Substance Abuse Treatment, 23, 343-350.
- Conditions
- Drug Addiction
- Being tested
- Continuing Care Telephone Support
- Keywords
- Stimulant, Drug treatment, Continuing care, Telephone support, Aftercare
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuing Care Telephone SupportBehavioural
Counselor-provided telephone support as strategies to promote patient aftercare attendance and sustained abstinence from stimulant use. To this end, we will develop and compare the efficacy of four low-cost telephone support protocols for patients who have completed the intensive phase of a structured, outpatient stimulant abuse treatment program.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Structured Directive Telephone Support Calls Receives: Behavioral: Continuing Care Telephone Support |
| 2 | Experimental | Structured Non-Directive Telephone Continuing Care Support Receives: Behavioral: Continuing Care Telephone Support |
| 3 | Experimental | Unstructured Directive Telephone Support Receives: Behavioral: Continuing Care Telephone Support |
| 4 | Experimental | Unstructured Non-Directive Telephone Support Receives: Behavioral: Continuing Care Telephone Support |
| 5 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinalyses
Measured: At 3 months and 12 months
Breathalyzer tests
Measured: At 3 months and 12 months
Self-report of drug or alcohol use
Measured: At 3 months and 12 months
Amount of Treatment Activities
Measured: At 3 months and 12 months
Length of Treatment Episode
Measured: At 3 months and 12 months
Secondary outcomes (4)
Addiction Severity Index (ASI)
Measured: At 3 months and 12 months
HIV Risk-taking Behavior Scale
Measured: At 3 months and 12 months
Concurrent Psychosocial Treatments
Measured: At 3 months and 12 months
Drug Avoidance Activities (DAA) Survey
Measured: At 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2008 (estimated)
- Study startApr 2006
- Primary completionSep 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- David Farabee, Ph.D., Principal investigator, UCLA Integrated Substance Abuse Programs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744068
- Sponsor's protocol ID
- R01DA018208-01A1
- Other IDs
- R01DA018208
- Status last verified
- Nov 2016
- First submitted
- 28 Aug 2008
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahles TA, Schlundt DG, Prue DM, Rychtarik RG. Impact of aftercare arrangements on the maintenance of treatment success in abusive drinkers. Addict Behav. 1983;8(1):53-8. doi: 10.1016/0306-4603(83)90056-4.
PubMed 6308970Allen K. Barriers to treatment for addicted African-American women. J Natl Med Assoc. 1995 Oct;87(10):751-6.
PubMed 7473850Ashery RS, Carlson RG, Falck RS, Siegal HA. Injection drug users, crack-cocaine users, and human services utilization: an exploratory study. Soc Work. 1995 Jan;40(1):75-82.
PubMed 7863375Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.
PubMed 3806354Battjes RJ, Onken LS, Delany PJ. Drug abuse treatment entry and engagement: report of a meeting on treatment readiness. J Clin Psychol. 1999 May;55(5):643-57. doi: 10.1002/(sici)1097-4679(199905)55:53.0.co;2-s.
PubMed 10392794Brown BS, O'Grady KE, Battjes RJ, Farrell EE, Smith NP, Nurco DN. Effectiveness of a stand-alone aftercare program for drug-involved offenders. J Subst Abuse Treat. 2001 Dec;21(4):185-92. doi: 10.1016/s0740-5472(01)00201-x.
PubMed 11777667Burton P, Gurrin L, Sly P. Extending the simple linear regression model to account for correlated responses: an introduction to generalized estimating equations and multi-level mixed modelling. Stat Med. 1998 Jun 15;17(11):1261-91. doi: 10.1002/(sici)1097-0258(19980615)17:113.0.co;2-z.
PubMed 9670414De Leon G, Melnick G, Kressel D, Jainchill N. Circumstances, motivation, readiness, and suitability (the CMRS scales): predicting retention in therapeutic community treatment. Am J Drug Alcohol Abuse. 1994 Nov;20(4):495-515. doi: 10.3109/00952999409109186.
PubMed 7832182De Leon G, Melnick G, Thomas G, Kressel D, Wexler HK. Motivation for treatment in a prison-based therapeutic community. Am J Drug Alcohol Abuse. 2000 Feb;26(1):33-46. doi: 10.1081/ada-100100589.
PubMed 10718162Dees SM, Dansereau DF, Peel JL, Boatler JG, Knight K. Using conceptual matrices, knowledge maps, and scripted cooperation to improve personal management strategies. J Drug Educ. 1991;21(3):211-30. doi: 10.2190/KJKM-F0UR-RDPH-8NUK.
PubMed 1919960Diez-Roux AV. Multilevel analysis in public health research. Annu Rev Public Health. 2000;21:171-92. doi: 10.1146/annurev.publhealth.21.1.171.
PubMed 10884951Farabee D, Rawson R, McCann M. Adoption of drug avoidance activities among patients in contingency management and cognitive-behavioral treatments. J Subst Abuse Treat. 2002 Dec;23(4):343-50. doi: 10.1016/s0740-5472(02)00297-0.
PubMed 12495796Fischer B, Chin AT, Kuo I, Kirst M, Vlahov D. Canadian illicit opiate users' views on methadone and other opiate prescription treatment: an exploratory qualitative study. Subst Use Misuse. 2002 Mar;37(4):495-522. doi: 10.1081/ja-120002807.
PubMed 12064431Fitzgerald JL, Mulford HA. An experimental test of telephone aftercare contacts with alcoholics. J Stud Alcohol. 1985 Sep;46(5):418-24. doi: 10.15288/jsa.1985.46.418.
PubMed 2999514Fortney JC, Booth BM, Blow FC, Bunn JY. The effects of travel barriers and age on the utilization of alcoholism treatment aftercare. Am J Drug Alcohol Abuse. 1995 Aug;21(3):391-406. doi: 10.3109/00952999509002705.
PubMed 7484987
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four Models of Telephone Support for Stimulant Recovery
- ClinicalTrials.gov ID
- NCT00744068
- Acronym / sponsor ID
- R01DA018208-01A1
- Conditions
- Drug Addiction
- Keywords
- Stimulant, Drug treatment, Continuing care, Telephone support, Aftercare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 29 Aug 2008 (estimated)
- 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.
The overall objective of this research is to develop and refine empirically supported continuing care interventions that promote healthy behavior and sustained abstinence from illicit drug use.
Detailed description
For treatment interventions to provide the desired result of long term abstinence, it is important to develop strategies to enhance the effectiveness of continued care approaches. We plan to conduct a prospective, randomized comparison of four models of counselor-provided telephone support as strategies to promote patient aftercare attendance and sustained abstinence from stimulant use. To this end, we will develop and compare the efficacy of four low-cost telephone support protocols for patients who have completed the intensive phase of a structured, outpatient stimulant abuse treatment program. Some 500 participants completing a 4-month Matrix Outpatient Model of stimulant abuse treatment will be randomly assigned to one of four counseling groups (n=100 per group): (1) unstructured/non-directive, (2) structured/non-directive, (3) unstructured/directive, or (4) structured/directive telephone counseling, or (5) a control group consisting of standard referral to Matrix aftercare, for a total sample size of 500. The two structured conditions will be based on the behavioral "prompts" identified by Farabee et al. (2002)* as being associated with drug avoidance. In the non-directive conditions, subjects will be allowed to state their own goals and how they intend to achieve them. In the directive conditions, the counselor will provide specific recommendations to help the subject adopt as many of the drug-avoidance activities as possible. Outcomes will be tracked for 12 months following completion of primary treatment (a total of 16 months after treatment admission) and will include measurement of participation in drug-avoidance activities (including aftercare participation) as well as self-reported and objective measures of substance use and related behavior change.
*Farabee, D., Rawson, R.A., \& McCann, M. (2002). Adoption of drug avoidance activities among patients in contingency management and cognitive-behavioral treatments. Journal of Substance Abuse Treatment, 23, 343-350.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Continuing Care Telephone SupportStructured Directive Telephone Support Calls |
| 2 | Experimental | Behavioral: Continuing Care Telephone SupportStructured Non-Directive Telephone Continuing Care Support |
| 3 | Experimental | Behavioral: Continuing Care Telephone SupportUnstructured Directive Telephone Support |
| 4 | Experimental | Behavioral: Continuing Care Telephone SupportUnstructured Non-Directive Telephone Support |
| 5 | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females, 18-65 years of age.
- Meet DSM-IV criteria (at the time of treatment admission) for cocaine or methamphetamine abuse/dependence.
- Have completed the primary phase of treatment at a Matrix outpatient clinic.
- Have telephone access throughout the study procedures.
- Be able to understand and complete rating scales and to follow instructions.
Key exclusion criteria (3 listed)
- Have participated in a treatment-related study conducted by the PI and colleagues during the previous 3 years and/or is currently enrolled in a treatment-related study.
- Have any medical, legal, housing or transportation problem which would preclude either safe or consistent participation.
- Have dropped out of the primary phase of treatment prior to completion.
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 |
|---|---|---|
| Continuing Care Telephone SupportCounselor-provided telephone support as strategies to promote patient aftercare attendance and sustained abstinence from stimulant use. To this end, we will develop and compare the efficacy of four low-cost telephone support protocols for patients who have completed the intensive phase of a structured, outpatient stimulant abuse treatment program. | Behavioural | 1, 2, 3, 4 |
Primary outcome
Urinalyses
Time frame: At 3 months and 12 months
Breathalyzer tests
Time frame: At 3 months and 12 months
Self-report of drug or alcohol use
Time frame: At 3 months and 12 months
Amount of Treatment Activities
Time frame: At 3 months and 12 months
Length of Treatment Episode
Time frame: At 3 months and 12 months
4 secondary outcomes
Addiction Severity Index (ASI)
Time frame: At 3 months and 12 months
HIV Risk-taking Behavior Scale
Time frame: At 3 months and 12 months
Concurrent Psychosocial Treatments
Time frame: At 3 months and 12 months
Drug Avoidance Activities (DAA) Survey
Time frame: At 3 months and 12 months
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 28 Nov 2016.
- Background: PubMed 6308970Ahles TA, Schlundt DG, Prue DM, Rychtarik RG. Impact of aftercare arrangements on the maintenance of treatment success in abusive drinkers. Addict Behav. 1983;8(1):53-8. doi: 10.1016/0306-4603(83)90056-4.
- Background: PubMed 7473850Allen K. Barriers to treatment for addicted African-American women. J Natl Med Assoc. 1995 Oct;87(10):751-6.
- Background: PubMed 7863375Ashery RS, Carlson RG, Falck RS, Siegal HA. Injection drug users, crack-cocaine users, and human services utilization: an exploratory study. Soc Work. 1995 Jan;40(1):75-82.
- Background: PubMed 3806354Baron RM, Kenny DA. The moderator-mediator variable distinction in social psychological research: conceptual, strategic, and statistical considerations. J Pers Soc Psychol. 1986 Dec;51(6):1173-82. doi: 10.1037//0022-3514.51.6.1173.
- Background: PubMed 10392794Battjes RJ, Onken LS, Delany PJ. Drug abuse treatment entry and engagement: report of a meeting on treatment readiness. J Clin Psychol. 1999 May;55(5):643-57. doi: 10.1002/(sici)1097-4679(199905)55:53.0.co;2-s.
- Background: PubMed 11777667Brown BS, O'Grady KE, Battjes RJ, Farrell EE, Smith NP, Nurco DN. Effectiveness of a stand-alone aftercare program for drug-involved offenders. J Subst Abuse Treat. 2001 Dec;21(4):185-92. doi: 10.1016/s0740-5472(01)00201-x.
- Background: PubMed 9670414Burton P, Gurrin L, Sly P. Extending the simple linear regression model to account for correlated responses: an introduction to generalized estimating equations and multi-level mixed modelling. Stat Med. 1998 Jun 15;17(11):1261-91. doi: 10.1002/(sici)1097-0258(19980615)17:113.0.co;2-z.
- Background: PubMed 7832182De Leon G, Melnick G, Kressel D, Jainchill N. Circumstances, motivation, readiness, and suitability (the CMRS scales): predicting retention in therapeutic community treatment. Am J Drug Alcohol Abuse. 1994 Nov;20(4):495-515. doi: 10.3109/00952999409109186.
- Background: PubMed 10718162De Leon G, Melnick G, Thomas G, Kressel D, Wexler HK. Motivation for treatment in a prison-based therapeutic community. Am J Drug Alcohol Abuse. 2000 Feb;26(1):33-46. doi: 10.1081/ada-100100589.
- Background: PubMed 1919960Dees SM, Dansereau DF, Peel JL, Boatler JG, Knight K. Using conceptual matrices, knowledge maps, and scripted cooperation to improve personal management strategies. J Drug Educ. 1991;21(3):211-30. doi: 10.2190/KJKM-F0UR-RDPH-8NUK.
- Background: PubMed 10884951Diez-Roux AV. Multilevel analysis in public health research. Annu Rev Public Health. 2000;21:171-92. doi: 10.1146/annurev.publhealth.21.1.171.
- Background: PubMed 12495796Farabee D, Rawson R, McCann M. Adoption of drug avoidance activities among patients in contingency management and cognitive-behavioral treatments. J Subst Abuse Treat. 2002 Dec;23(4):343-50. doi: 10.1016/s0740-5472(02)00297-0.
- Related InfoLink provided by the sponsor.
Related trials for Drug Addiction
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingObservational study
Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
Opioid-Related Disorders, Drug Addiction
Recruiting
Fighting Addictions, Improving Lives: COmprehensive Drug Rehabilitation With Music
Substance Use Disorder (SUD)
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.
David Farabee, Ph.D. principal investigator
UCLA Integrated Substance Abuse Programs
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuing Care Telephone Support in people with Drug Addiction, run by University of California, Los Angeles at 6 sites 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 6 inclusion and 3 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 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Urinalyses (time frame: At 3 months and 12 months). The study lists 5 primary outcomes in all. 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 NCT00744068, which also lists 48 linked publications.
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 28 Nov 2016.