Alcohol DependenceGMI-IHMDsNCT00706901
Impact of Group Motivational Interviewing and In-Home-Messaging-Devices for Dually Diagnosed Veterans
A study testing Arm 1 GMI, Arm 2 IHMD and Arm 3 TCC in people with Alcohol Dependence and Dual Diagnosis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Two approaches for providing evidence-based substance abuse treatment (EBT), group motivational interviewing (GMI) and the In-Home-Messaging-Device (IHMD), are interventions that have the characteristic ability for increasing accessibility to evidence-based treatment among patients with substance use problems and are… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Alcohol Dependence, Dual Diagnosis, Drug Dependence
- What is being tested?
- Arm 1 GMI, Arm 2 IHMD and Arm 3 TCC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2010to 30 Sep 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ability to provide informed consent
- reading level at least at the 5th grade level
- ability to identify at least one collateral contact
- ability to be contacted by telephone at follow-up
- access to a working telephone line in the home or residential placement
- alcohol use or alcohol and drug use in the 28 days prior to hospitalization and current alcohol dependence (or abuse) or alcohol and drug abuse
Who cannot join
- auditory or visual impairment that would interfere with study procedures
- scheduled for discharge within 72 hours of initial screening
- diagnosis of dementia
- inability to speak or understand English
- unable to access a landline telephone for the IHMD treatment group
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5799
About this study
Official title: Impact of Group Motivational Interviewing for Dually Diagnosed Veterans
Two approaches for providing evidence-based substance abuse treatment (EBT), group motivational interviewing (GMI) and the In-Home-Messaging-Device (IHMD), are interventions that have the characteristic ability for increasing accessibility to evidence-based treatment among patients with substance use problems and are proposed for investigation. GMI is based on motivational interviewing, an intervention that has shown consistent significant effects in promoting treatment retention and reduced substance use among individuals with substance use disorders, and is delivered in a group format. IHMD is a user-friendly computerized Tele-mental Health communication tool that allows interaction through the telephone line between a Veteran and the health care provider in an individual's home or residential placement. The current proposal aims to determine whether GMI and IHMD lead to a significantly greater increase in treatment engagement and reduction in alcohol use compared to a treatment control condition (TCC) among Veterans with a substance use problem and a co-existing psychiatric disorder.
Read the detailed description
Dually diagnosed Veterans (N = 178) will be recruited from the Charleston, SC VAMC Outpatient Substance Abuse Treatment Center (SATC) and block randomized to TAU, GMI, or IHMD. Patients with alcohol dependence or abuse (including drug abuse) and a nonsubstance-related major Axis I disorder (e.g., bipolar disorder, depression, psychotic disorder) will be eligible for the study. Participants, who were referred to the study at time of triage or during the orientation phase of SATC, will be evaluated at baseline and approximately at a 1 and 3-month follow-up. Primary outcome measures will be alcohol use and treatment utilization as measured by number of days of alcohol use, number of binge alcohol drinking days, and quantity of alcohol consumed (in standard drinks, or SECs), and treatment attendance sessions based on objective CPRS patient medical records (i.e., number of all substance abuse outpatient, other mental health [e.g., PTSD, depression], and other substance abuse treatment sessions), and self-reported 12-step (number of self-help AA/NA) sessions, including days consulting with a 12-step or mutual self-help sponsor. Exploratory outcomes measures include number of illicit drug use days (e.g., cocaine, crack, marijuana, opiates, and sedatives).
Primary questions:
- Does GMI lead to a significantly greater reduction in alcohol use and an increase in treatment engagement outcomes in the 3-month follow-up period compared to participants assigned to TCC?
Hypothesis: Participants who receive GMI will consume less alcohol and will be engaged in and attend more continuous treatment than participants in TCC in the 3-month follow-up period.
- Does IHMD lead to a significantly greater reduction in alcohol use and an increase in treatment engagement outcomes in the 3-month follow-up period compared to participants assigned to TCC?
Hypothesis: Participants who receive IHMD will consume less alcohol and will be engaged in and attend more continuous treatment than participants in TCC in the 3-month follow-up period.
Exploratory question:
Compared to TCC, will GMI and IHMD lead to significantly fewer days of illicit drug use by 3-month follow-up?
Hypothesis: Compared to TCC, GMI and IHMD will result in a significant reduction in days of illicit drug use by 3-month follow-up.
- Conditions
- Alcohol Dependence, Dual Diagnosis, Drug Dependence
- Being tested
- Arm 1 GMI, Arm 2 IHMD, Arm 3 TCC
- Keywords
- MI, IHMD
- Medical subject headings
- Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1 GMIBehavioural
Participants randomized to GMI received four structured, back-to-back, 75-minute sessions in one week consistent with the central principles and spirit of MI (Miller \& Rollnick 2013) and based on a manualized protocol (Martino \& Santa Ana 2013; Santa Ana \& Martino, 2009). Designed for dually diagnosed patients, a focus of the intervention is to examine the relationship between the substance use and the co-existing psychiatric disorder(s) and the importance of proactively treating both conditions.
Arm 2 IHMDBehavioural
Participants randomized to IHMD received a 27 day VA Care Coordination Home Telehealth (CCHT) program targeting acute recovery from alcohol and other drug disorders. IHMD consisted of daily assessment combined with dialogues consisting of motivational interviewing, cognitive behavioral therapy, and 12-step (mutual self-help) facilitation.
Arm 3 TCCBehavioural
TCC consisted of a 4-session psychoeducational group (75 minutes per session). Material was delivered using a power point presentation on topics
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 GMI | Experimental | Patients randomized to GMI received four structured 75-minute sessions consistent with the central principles and style of motivational interviewing (Miller \& Rollnick, 2012). The goal of MI is to develop a sense of discrepancy between personal goals and current behavior and enhance change talk among participants, particularly for taking responsibility of one's substance use and being proactive for remaining in treatment. Receives: Behavioral: Arm 1 GMI; Behavioral: Arm 3 TCC |
| Arm 2 IHMD | Experimental | Participants randomized to In-Home-Messaging Devices (IHMD) received a 27-day Care Coordination Home Telehealth (CCHT) program targeting their acute recovery from alcohol and other substance use disorder. Participants received their IHMD device through the Charleston VAMC CCHT program, including device accessories and a phone number to reach their CCHT provider. They were provided with specific instructions on how to set up their IHMD in their residence after discharge. The research associate followed-up with the patient one day after receiving the device to ensure that the device was successfully set up and to provide assistance as necessary. Participants received standard VA CCHT services. Receives: Behavioral: Arm 2 IHMD; Behavioral: Arm 3 TCC |
| Arm 3 TCC | Active comparator | Participants randomized to the Treatment Control Condition (TCC) received a psycho-educational group (e.g., addiction as a chronic disease, relapse prevention, developing a plan to prevent relapse) that was delivered with the aid of sequential standardized PowerPoint presentations. Group members were encouraged to ask questions and make comments. Therapists were encouraged to conduct the sessions using an instructional quality that minimized the use of GMI strategies. TCC consisted of four sessions, lasting 75 minutes, and was conducted on four consecutive days within the course of one week. Receives: Behavioral: Arm 3 TCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Number of alcohol drinking days is the number of days that that participant self-reported having at least 1 standard alcohol beverage during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).
Measured: One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days
Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Number of alcohol binge drinking days is the number of days that that participant self-reported having at least 4 standard alcohol beverages on one occasion (for women) and at least 5 standard alcohol beverages on one occasion (for men) during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).
Measured: One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days
Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Standard drinks, or SECs, is the number of drinks that the participant self-reported consuming (as measured by 0.5 oz ethanol alcohol per beverage) during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).
Measured: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Treatment utilization is the number of treatment attendance sessions based on objective CPRS medical records, including number of all VA substance abuse outpatient, other mental health (e.g., PTSD, depression), and other substance abuse treatment sessions.
Measured: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Number of self-reported 12-step (number of self-help alcoholics anonymous or narcotics anonymous [AA/NA]) sessions, including days of consulting with a 12-step sponsor for help with a substance use problem based on the Time Line Follow-Back (Sobell \& Sobell, 1992).
Measured: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Secondary outcomes (1)
Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Number of illicit drug use days is the number of days that that participant self-reported having used illicit drug (e.g., cocaine, crack, marijuana, opiates, sedatives, hallucinogens) during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).
Measured: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2008 (estimated)
- Study start3 May 2010
- Primary completion30 Jun 2013
- Study completion30 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Elizabeth J. Santa Ana, PhD MA BA, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706901
- Sponsor's protocol ID
- CDA-2-016-08S
- Other IDs
- IIR 13-317-2
- Acronym
- GMI-IHMDs
- Status last verified
- Jul 2018
- First submitted
- 26 Jun 2008
- Last updated
- 8 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Price KL, Baker NL, McRae-Clark AL, Saladin ME, Desantis SM, Santa Ana EJ, Brady KT. A randomized, placebo-controlled laboratory study of the effects of D-cycloserine on craving in cocaine-dependent individuals. Psychopharmacology (Berl). 2013 Apr;226(4):739-46. doi: 10.1007/s00213-011-2592-x. Epub 2012 Jan 11.
PubMed 22234379Prisciandaro JJ, Myrick H, Henderson S, McRae-Clark AL, Santa Ana EJ, Saladin ME, Brady KT. Impact of DCS-facilitated cue exposure therapy on brain activation to cocaine cues in cocaine dependence. Drug Alcohol Depend. 2013 Sep 1;132(1-2):195-201. doi: 10.1016/j.drugalcdep.2013.02.009. Epub 2013 Mar 14.
PubMed 23497788Santa Ana EJ, Stallings DL, Rounsaville BJ, Martino S. Development of an in-home telehealth program for outpatient veterans with substance use disorders. Psychol Serv. 2013 Aug;10(3):304-314. doi: 10.1037/a0026511. Epub 2011 Dec 12.
PubMed 23937090
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Group Motivational Interviewing for Dually Diagnosed Veterans
- ClinicalTrials.gov ID
- NCT00706901
- Acronym / sponsor ID
- GMI-IHMDs / CDA-2-016-08S
- Conditions
- Alcohol Dependence, Dual Diagnosis, Drug Dependence
- Keywords
- MI, IHMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 May 2010 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 30 Sep 2013 (actual)
- First posted
- 30 Jun 2008 (estimated)
- Results
- Posted 4 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Two approaches for providing evidence-based substance abuse treatment (EBT), group motivational interviewing (GMI) and the In-Home-Messaging-Device (IHMD), are interventions that have the characteristic ability for increasing accessibility to evidence-based treatment among patients with substance use problems and are proposed for investigation. GMI is based on motivational interviewing, an intervention that has shown consistent significant effects in promoting treatment retention and reduced substance use among individuals with substance use disorders, and is delivered in a group format. IHMD is a user-friendly computerized Tele-mental Health communication tool that allows interaction through the telephone line between a Veteran and the health care provider in an individual's home or residential placement. The current proposal aims to determine whether GMI and IHMD lead to a significantly greater increase in treatment engagement and reduction in alcohol use compared to a treatment control condition (TCC) among Veterans with a substance use problem and a co-existing psychiatric disorder.
Detailed description
Dually diagnosed Veterans (N = 178) will be recruited from the Charleston, SC VAMC Outpatient Substance Abuse Treatment Center (SATC) and block randomized to TAU, GMI, or IHMD. Patients with alcohol dependence or abuse (including drug abuse) and a nonsubstance-related major Axis I disorder (e.g., bipolar disorder, depression, psychotic disorder) will be eligible for the study. Participants, who were referred to the study at time of triage or during the orientation phase of SATC, will be evaluated at baseline and approximately at a 1 and 3-month follow-up. Primary outcome measures will be alcohol use and treatment utilization as measured by number of days of alcohol use, number of binge alcohol drinking days, and quantity of alcohol consumed (in standard drinks, or SECs), and treatment attendance sessions based on objective CPRS patient medical records (i.e., number of all substance abuse outpatient, other mental health [e.g., PTSD, depression], and other substance abuse treatment sessions), and self-reported 12-step (number of self-help AA/NA) sessions, including days consulting with a 12-step or mutual self-help sponsor. Exploratory outcomes measures include number of illicit drug use days (e.g., cocaine, crack, marijuana, opiates, and sedatives).
Primary questions:
- Does GMI lead to a significantly greater reduction in alcohol use and an increase in treatment engagement outcomes in the 3-month follow-up period compared to participants assigned to TCC?
Hypothesis: Participants who receive GMI will consume less alcohol and will be engaged in and attend more continuous treatment than participants in TCC in the 3-month follow-up period.
- Does IHMD lead to a significantly greater reduction in alcohol use and an increase in treatment engagement outcomes in the 3-month follow-up period compared to participants assigned to TCC?
Hypothesis: Participants who receive IHMD will consume less alcohol and will be engaged in and attend more continuous treatment than participants in TCC in the 3-month follow-up period.
Exploratory question:
Compared to TCC, will GMI and IHMD lead to significantly fewer days of illicit drug use by 3-month follow-up?
Hypothesis: Compared to TCC, GMI and IHMD will result in a significant reduction in days of illicit drug use by 3-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 GMI | Experimental | Behavioral: Arm 1 GMI, Behavioral: Arm 3 TCCPatients randomized to GMI received four structured 75-minute sessions consistent with the central principles and style of motivational interviewing (Miller \& Rollnick, 2012). The goal of MI is to develop a sense of discrepancy between personal goals and current behavior and enhance change talk among participants, particularly for taking responsibility of one's substance use and being proactive for remaining in treatment. |
| Arm 2 IHMD | Experimental | Behavioral: Arm 2 IHMD, Behavioral: Arm 3 TCCParticipants randomized to In-Home-Messaging Devices (IHMD) received a 27-day Care Coordination Home Telehealth (CCHT) program targeting their acute recovery from alcohol and other substance use disorder. Participants received their IHMD device through the Charleston VAMC CCHT program, including device accessories and a phone number to reach their CCHT provider. They were provided with specific instructions on how to set up their IHMD in their residence after discharge. The research associate followed-up with the patient one day after receiving the device to ensure that the device was successfully set up and to provide assistance as necessary. Participants received standard VA CCHT services. |
| Arm 3 TCC | Active comparator | Behavioral: Arm 3 TCCParticipants randomized to the Treatment Control Condition (TCC) received a psycho-educational group (e.g., addiction as a chronic disease, relapse prevention, developing a plan to prevent relapse) that was delivered with the aid of sequential standardized PowerPoint presentations. Group members were encouraged to ask questions and make comments. Therapists were encouraged to conduct the sessions using an instructional quality that minimized the use of GMI strategies. TCC consisted of four sessions, lasting 75 minutes, and was conducted on four consecutive days within the course of one week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ability to provide informed consent
- reading level at least at the 5th grade level
- ability to identify at least one collateral contact
- ability to be contacted by telephone at follow-up
- access to a working telephone line in the home or residential placement
Key exclusion criteria (5 listed)
- auditory or visual impairment that would interfere with study procedures
- scheduled for discharge within 72 hours of initial screening
- diagnosis of dementia
- inability to speak or understand English
- unable to access a landline telephone for the IHMD treatment group
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 |
|---|---|---|
| Arm 1 GMIParticipants randomized to GMI received four structured, back-to-back, 75-minute sessions in one week consistent with the central principles and spirit of MI (Miller \& Rollnick 2013) and based on a manualized protocol (Martino \& Santa Ana 2013; Santa Ana \& Martino, 2009). Designed for dually diagnosed patients, a focus of the intervention is to examine the relationship between the substance use and the co-existing psychiatric disorder(s) and the importance of proactively treating both conditions. | Behavioural | Arm 1 GMI |
| Arm 2 IHMDParticipants randomized to IHMD received a 27 day VA Care Coordination Home Telehealth (CCHT) program targeting acute recovery from alcohol and other drug disorders. IHMD consisted of daily assessment combined with dialogues consisting of motivational interviewing, cognitive behavioral therapy, and 12-step (mutual self-help) facilitation. | Behavioural | Arm 2 IHMD |
| Arm 3 TCCTCC consisted of a 4-session psychoeducational group (75 minutes per session). Material was delivered using a power point presentation on topics | Behavioural | Arm 1 GMI, Arm 2 IHMD, Arm 3 TCC |
Primary outcome
Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Time frame: One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days
Number of alcohol drinking days is the number of days that that participant self-reported having at least 1 standard alcohol beverage during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).
Number of Alcohol Binge Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Time frame: One and three-months post intervention in the previous 30 (one month follow up) and 60 (three month follow up) days
Number of alcohol binge drinking days is the number of days that that participant self-reported having at least 4 standard alcohol beverages on one occasion (for women) and at least 5 standard alcohol beverages on one occasion (for men) during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).
Standard Number of Alcohol Drinks in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Time frame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Standard drinks, or SECs, is the number of drinks that the participant self-reported consuming (as measured by 0.5 oz ethanol alcohol per beverage) during the specified follow up period on the Time Line Follow Back (Sobell \& Sobell, 1992).
Treatment Utilization in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Time frame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Treatment utilization is the number of treatment attendance sessions based on objective CPRS medical records, including number of all VA substance abuse outpatient, other mental health (e.g., PTSD, depression), and other substance abuse treatment sessions.
Treatment Attendance at 12-step or Mutual Self-help Sessions in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Time frame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Number of self-reported 12-step (number of self-help alcoholics anonymous or narcotics anonymous [AA/NA]) sessions, including days of consulting with a 12-step sponsor for help with a substance use problem based on the Time Line Follow-Back (Sobell \& Sobell, 1992).
1 secondary outcome
Number of Illicit Drug Use Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Time frame: One and three-months post intervention in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22234379Price KL, Baker NL, McRae-Clark AL, Saladin ME, Desantis SM, Santa Ana EJ, Brady KT. A randomized, placebo-controlled laboratory study of the effects of D-cycloserine on craving in cocaine-dependent individuals. Psychopharmacology (Berl). 2013 Apr;226(4):739-46. doi: 10.1007/s00213-011-2592-x. Epub 2012 Jan 11.
- Results publication: PubMed 23497788Prisciandaro JJ, Myrick H, Henderson S, McRae-Clark AL, Santa Ana EJ, Saladin ME, Brady KT. Impact of DCS-facilitated cue exposure therapy on brain activation to cocaine cues in cocaine dependence. Drug Alcohol Depend. 2013 Sep 1;132(1-2):195-201. doi: 10.1016/j.drugalcdep.2013.02.009. Epub 2013 Mar 14.
- Results publication: PubMed 23937090Santa Ana EJ, Stallings DL, Rounsaville BJ, Martino S. Development of an in-home telehealth program for outpatient veterans with substance use disorders. Psychol Serv. 2013 Aug;10(3):304-314. doi: 10.1037/a0026511. Epub 2011 Dec 12.
- Individual participant dataSharing planned: Undecided
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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.
Elizabeth J. Santa Ana, PhD MA BA principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1 GMI, Arm 2 IHMD and Arm 3 TCC in people with Alcohol Dependence and Dual Diagnosis, run by VA Office of Research and Development 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 6 inclusion and 5 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 8 Aug 2018. 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?
Yes. Results are posted in the registry (first posted 4 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Alcohol Drinking Days in the Previous 30 (One Month Follow up) and 60 (Three Month Follow up) Days (time frame: One month follow-up and three month follow up in the previous 30 (one month follow up) and 60 (three month follow up) days). 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 NCT00706901, which also lists 3 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 8 Aug 2018.