Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00744068
Other study ID # R01DA018208-01A1
Secondary ID R01DA018208
Status Completed
Phase N/A
First received August 28, 2008
Last updated November 23, 2016
Start date April 2006
Est. completion date September 2011

Study information

Verified date November 2016
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 302
Est. completion date September 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Continuing Care Telephone Support
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.

Locations

Country Name City State
United States Twin Town Treatment Center Los Alamitos California
United States Matrix Institute on Addictions Los Angeles California
United States UCLA Integrated Substance Abuse Programs Los Angeles California
United States Matrix Institute on Addictions Rancho Cucamonga California
United States Twin Town Treatment Center West Hollywood California
United States Matrix Institute on Addicitions Woodland Hills California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (48)

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. — View Citation

Allen K. Barriers to treatment for addicted African-American women. J Natl Med Assoc. 1995 Oct;87(10):751-6. — View Citation

Ashery 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. — View Citation

Baron 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. — View Citation

Battjes 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. — View Citation

Brown 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. — View Citation

Burton 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. — View Citation

De 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. — View Citation

De 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. — View Citation

Dees 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. — View Citation

Diez-Roux AV. Multilevel analysis in public health research. Annu Rev Public Health. 2000;21:171-92. Review. — View Citation

Farabee D, Cousins SJ, Brecht ML, Antonini VP, Lee AB, Brummer J, Hemberg J, Karno M, Rawson RA. A comparison of four telephone-based counseling styles for recovering stimulant users. Psychol Addict Behav. 2013 Mar;27(1):223-9. doi: 10.1037/a0029572. — View Citation

Farabee 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. — View Citation

Fischer 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. — View Citation

Fitzgerald JL, Mulford HA. An experimental test of telephone aftercare contacts with alcoholics. J Stud Alcohol. 1985 Sep;46(5):418-24. — View Citation

Fortney 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. — View Citation

Haynes RB, McDonald HP, Garg AX. Helping patients follow prescribed treatment: clinical applications. JAMA. 2002 Dec 11;288(22):2880-3. — View Citation

Hser YI, Anglin D, Powers K. A 24-year follow-up of California narcotics addicts. Arch Gen Psychiatry. 1993 Jul;50(7):577-84. — View Citation

Hser YI, Hoffman V, Grella CE, Anglin MD. A 33-year follow-up of narcotics addicts. Arch Gen Psychiatry. 2001 May;58(5):503-8. — View Citation

Huber A, Ling W, Shoptaw S, Gulati V, Brethen P, Rawson R. Integrating treatments for methamphetamine abuse: a psychosocial perspective. J Addict Dis. 1997;16(4):41-50. — View Citation

Huber A, Lord RH, Gulati V, Marinelli-Casey P, Rawson R, Ling W. The CSAT methamphetamine treatment program: research design accommodations for "real world" application. J Psychoactive Drugs. 2000 Apr-Jun;32(2):149-56. — View Citation

Hunt WA, Barnett LW, Branch LG. Relapse rates in addiction programs. J Clin Psychol. 1971 Oct;27(4):455-6. — View Citation

Iguchi MY, Belding MA, Morral AR, Lamb RJ, Husband SD. Reinforcing operants other than abstinence in drug abuse treatment: an effective alternative for reducing drug use. J Consult Clin Psychol. 1997 Jun;65(3):421-8. — View Citation

Intagliata J. A telephone follow-up procedure for increasing the effectiveness of a treatment program for alcoholics. J Stud Alcohol. 1976 Sep;37(9):1330-5. — View Citation

Karno MP, Beutler LE, Harwood TM. Interactions between psychotherapy procedures and patient attributes that predict alcohol treatment effectiveness: a preliminary report. Addict Behav. 2002 Sep-Oct;27(5):779-97. — View Citation

Koumans AJ, Muller JJ, Miller CF. Use of telephone calls to increase motivation for treatment in alcoholics. Psychol Rep. 1967 Aug;21(1):327-8. — View Citation

Lash SJ, Blosser SL. Increasing adherence to substance abuse aftercare group therapy. J Subst Abuse Treat. 1999 Jan;16(1):55-60. — View Citation

Lash SJ, Dillard W. Encouraging participation in aftercare group therapy among substance-dependent men. Psychol Rep. 1996 Oct;79(2):585-6. — View Citation

Lovejoy M, Rosenblum A, Magura S, Foote J, Handelsman L, Stimmel B. Patients' perspective on the process of change in substance abuse treatment. J Subst Abuse Treat. 1995 Jul-Aug;12(4):269-82. — View Citation

MacKinnon DP, Lockwood CM, Hoffman JM, West SG, Sheets V. A comparison of methods to test mediation and other intervening variable effects. Psychol Methods. 2002 Mar;7(1):83-104. — View Citation

McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions: scientific review. JAMA. 2002 Dec 11;288(22):2868-79. Review. Erratum in: JAMA. 2003 Jun 25;289(24):3242. — View Citation

McKay JR, McLellan AT, Alterman AI, Cacciola JS, Rutherford MJ, O'Brien CP. Predictors of participation in aftercare sessions and self-help groups following completion of intensive outpatient treatment for substance abuse. J Stud Alcohol. 1998 Mar;59(2):152-62. — View Citation

McKay JR. Effectiveness of continuing care interventions for substance abusers. Implications for the study of long-term treatment effects. Eval Rev. 2001 Apr;25(2):211-32. Review. — View Citation

Ouimette PC, Moos RH, Finney JW. Influence of outpatient treatment and 12-step group involvement on one-year substance abuse treatment outcomes. J Stud Alcohol. 1998 Sep;59(5):513-22. — View Citation

Pan W. Sample size and power calculations with correlated binary data. Control Clin Trials. 2001 Jun;22(3):211-27. — View Citation

Peterson KA, Swindle RW, Phibbs CS, Recine B, Moos RH. Determinants of readmission following inpatient substance abuse treatment: a national study of VA programs. Med Care. 1994 Jun;32(6):535-50. — View Citation

Rawson RA, Marinelli-Casey P, Anglin MD, Dickow A, Frazier Y, Gallagher C, Galloway GP, Herrell J, Huber A, McCann MJ, Obert J, Pennell S, Reiber C, Vandersloot D, Zweben J; Methamphetamine Treatment Project Corporate Authors.. A multi-site comparison of psychosocial approaches for the treatment of methamphetamine dependence. Addiction. 2004 Jun;99(6):708-17. — View Citation

Rawson RA, Obert JL, McCann MJ, Ling W. Neurobehavioral treatment for cocaine dependency: a preliminary evaluation. NIDA Res Monogr. 1993;135:92-115. Review. — View Citation

Rawson RA, Shoptaw SJ, Obert JL, McCann MJ, Hasson AL, Marinelli-Casey PJ, Brethen PR, Ling W. An intensive outpatient approach for cocaine abuse treatment. The Matrix model. J Subst Abuse Treat. 1995 Mar-Apr;12(2):117-27. — View Citation

Richter KP, Bammer G. A hierarchy of strategies heroin-using mothers employ to reduce harm to their children. J Subst Abuse Treat. 2000 Dec;19(4):403-13. — View Citation

Rochon J. Application of GEE procedures for sample size calculations in repeated measures experiments. Stat Med. 1998 Jul 30;17(14):1643-58. — View Citation

Shoptaw S, Rawson RA, McCann MJ, Obert JL. The Matrix model of outpatient stimulant abuse treatment: evidence of efficacy. J Addict Dis. 1994;13(4):129-41. — View Citation

Shrout PE, Bolger N. Mediation in experimental and nonexperimental studies: new procedures and recommendations. Psychol Methods. 2002 Dec;7(4):422-45. — View Citation

Silverman K, Higgins ST, Brooner RK, Montoya ID, Cone EJ, Schuster CR, Preston KL. Sustained cocaine abstinence in methadone maintenance patients through voucher-based reinforcement therapy. Arch Gen Psychiatry. 1996 May;53(5):409-15. — View Citation

Sobell LC, Maisto SA, Sobell MB, Cooper AM. Reliability of alcohol abusers' self-reports of drinking behavior. Behav Res Ther. 1979;17(2):157-60. — View Citation

Spitzer RL, Williams JB, Gibbon M, First MB. The Structured Clinical Interview for DSM-III-R (SCID). I: History, rationale, and description. Arch Gen Psychiatry. 1992 Aug;49(8):624-9. — View Citation

Stahler GJ, Cohen E. Using ethnographic methodology in substance abuse treatment outcome research. J Subst Abuse Treat. 2000 Jan;18(1):1-8. — View Citation

Stout RL, Wirtz PW, Carbonari JP, Del Boca FK. Ensuring balanced distribution of prognostic factors in treatment outcome research. J Stud Alcohol Suppl. 1994 Dec;12:70-5. — View Citation

* Note: There are 48 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Urinalyses At 3 months and 12 months No
Primary Breathalyzer tests At 3 months and 12 months No
Primary Self-report of drug or alcohol use At 3 months and 12 months No
Primary Amount of Treatment Activities At 3 months and 12 months No
Primary Length of Treatment Episode At 3 months and 12 months No
Secondary Addiction Severity Index (ASI) At 3 months and 12 months No
Secondary HIV Risk-taking Behavior Scale At 3 months and 12 months No
Secondary Concurrent Psychosocial Treatments At 3 months and 12 months No
Secondary Drug Avoidance Activities (DAA) Survey At 3 months and 12 months No
See also
  Status Clinical Trial Phase
Completed NCT02939352 - The Effects of Theta Burst Stimulation on the Brain Response to Drug and Alcohol Cues Early Phase 1
Completed NCT02282306 - Phone Interview to Prevent Recurring Opioid Overdoses N/A
Completed NCT02224508 - Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks N/A
Completed NCT02192931 - A Randomized Double-Blind Controlled Trial of Creatine in Female Methamphetamine Users Phase 4
Completed NCT02437123 - The Cedar Project: Impact of mHealth for HIV Prevention Among Young Indigenous People Who Use Illicit Drugs N/A
Completed NCT01685073 - The Role of Sleep in the Treatment of Cannabis Use Disorders Phase 2/Phase 3
Completed NCT01591239 - Home-Based Program to Help Parents of Drug Abusing Adolescents N/A
Completed NCT00317460 - Buprenorphine and Integrated HIV Care Phase 4
Completed NCT03678051 - CBT4CBT for Women in Residential Treatment for Substance Use Disorders N/A
Completed NCT04105621 - Westlake Personalized Nutrition and Health Cohort for Drug Addicts
Withdrawn NCT05440721 - Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification N/A
Completed NCT03694327 - Innovative Digital Therapeutic for Smoking Cessation N/A
Completed NCT00496990 - Treating the Partners of Drug Using Pregnant Women: Stage II Phase 2/Phase 3
Completed NCT00244699 - Integrating Mindfulness-Based Skills Training Into Brief Outpatient Treatment for Substance Abusing Youth N/A
Completed NCT00390559 - Examining the Effect of the Nicotine Patch in Male and Female Smokers - 3 N/A
Completed NCT03402672 - AWAITS: A Web-based E-health Application for Active Illicit Opioid Users N/A
Completed NCT03411265 - RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing N/A
Completed NCT01003496 - Comparing Acute and Continuous Drug Abuse Treatment: A Randomized Clinical Trial Phase 3
Completed NCT02091284 - Bilateral Prefrontal Modulation in Alcoholism N/A
Completed NCT02091167 - Bilateral Prefrontal Modulation in Crack-cocaine Addiction Phase 2

External Links