MTPMarijuana Treatment Project

The Multi-site Study of the Effectivenessof Brief Treatment for Cannabis Dependence

A Cooperative Agreement funded by

SAMHSA-CSAT

Are brief treatments more effective than deferred treatment (referral to a waiting list control group)?

Does a 9 session treatment produce better outcomes than a 2 session treatment?

Do these treatments vary in effectiveness in diverse population groups in relation to gender, ethnicity, and employment status?

Primary Research Questions

Rationale for a Multi-site Trial

Marijuana is the most commonly abused illicit substance in the U.S.

Large numbers of chronic users have developed cannabis dependence

Previous small-scale clinical trials have demonstrated the efficacy of brief and extended treatments

Further research is needed to test the robustness of effect and its generalizability to broad populations

MTP Collaborating Sites

Sponsoring Agency Substance Abuse and Mental Health Services Administration/ Center for

Substance Abuse Treatment

Coordinating Center University of Connecticut, School of Medicine, Farmington, CT

Yale University, New Haven, CT

Clinical Research Units University of Washington, Seattle, WA University of Connecticut, School of Medicine, Farmington, CT The Village, Inc., Miami, FL

Experimental Groups

Brief Treatment Group (N=146) 2 sessions of Motivational Enhancement Therapy Delivered over a 5-week period

Extended Treatment Group (N=156) 9 sessions: 2 of Motivational Enhancement Therapy,

5 of Cognitive Behavioral Therapy, and 2 of Clinical Case Management

Delivered over a 12-week period

Delayed Treatment Control Group (N=148) Treatment initiation scheduled 4 months after date of study

enrollment Choice of brief or extended treatment at end of delay period

Study Design

D e la y e dT r e a tm e nt C o ntr o l

(D T C )

F o llo w -up E v a lua t io n4 , 9 , a nd 1 5 m o nths

B r ie fT r e a tm e nt

(B T )

E xte nd e dT r e a tm e nt

(E T )

R a nd o m A ss ig nm e nt

B a se line A sse ssm e nt

E nr o llm e nta nd

Info r m e d C o nse nt

S c r e e n ing fo r E lig ib ility

R e c r ut im e nt o f 4 5 0 c hr o nic m a r ijua na use r s thr o ug ha d v e r t is ing a nd r e fe r r a l

Overview of the Cognitive Study

Purpose To evaluate the effects of short-term (4-months)

abstinence on recovery of cognitive functioning

Design Cognitive assessment battery administered to

DTC volunteers at beginning and end of treatment Treatment responders (abstainers) will be

compared with clients who continue to use MJ

Assessment Procedures & Variables

MTP Screening Questionnaire Demographics Current alcohol and drug use Lifetime dependence history Medical and psychiatric history

Structured Clinical Interview for DSM-IV DSM-IV criteria for alcohol and drug abuse and

marijuana dependence

Time Line Follow-Back Interview Weekly summary data for frequency of marijuana, alcohol and

other drug use for ‘past 90 days’ Summary of quantity of marijuana, alcohol, cigarette use for ‘past

90 days' Hazardous use of marijuana for ‘past 90 days’

Addiction Severity Index Lifetime & current alcohol and drug history Medical history Employment and support status Legal history Psychiatric history

Assessment Procedures & Variables

Assessment Procedures & Variables

Self Report Questionnaires Beck Depression Inventory Self Efficacy Questionnaire Reasons for Quitting Marijuana Problem Scale Readiness to Change Questionnaire Coping Strategies Scales Ambivalence Measure State-Trait Anxiety Inventory

Urinalysis 10 Psychoactive Substances

Inclusion/Exclusion Criteria

Meets DSM-IV Diagnosis for Cannabis Dependence

Has smoked cannabis on at least 40 of the last 90 days

Does not meet DSM-IV dependence criteria for other drugs or alcohol

Is not involved in concurrent therapy or 12-step meetings

Does not have a medical or psychiatric diagnosis that would interfere with treatment

Is within 60 miles of clinic

Is able to name one person to serve as a locator

Has legal status that allows involvement in the protocol

Is not subject to mandatory urine screens

Is at least 18 years old

Has the ability to speak and understand English

Inclusion/Exclusion Criteria, cont.

Demographic Characteristics of MTP Participants (N=450)

Characteristic

Mean Age 36

SexMaleFemale

68%32%

EthnicityEuropean AmericanAfrican AmericanHispanic AmericanOther

69%17%12%02%

Demographic Characteristics of MTP Participants, cont. (N=450)

Characteristic

Marital StatusNot MarriedMarried/Cohabiting

60%40%

Mean Years Education 14

EmployedFull TimePart TimeUnemployedStudent/Retired/Homemaker

69%14%12%05%

Mean Number Years/Present Job 5

Marijuana Use Characteristics at Baseline (N=450)

Characteristic Mean (SD)

Number of Years of RegularMarijuana Use

17.94(7.73)

Number of Years of ProblemMarijuana Use

8.92(7.64)

Number of Endorsed MarijuanaDependence Symptoms (of 7)

5.36(1.26)

Number of Endorsed Marijuana-Related Problems (of 19)

9.38(3.55)

Marijuana Dependence Symptoms Endorsed at Baseline (N=450)

Symptom

MJ taken in larger amounts or over a longerperiod than intended

77%

Persistent desire or one or more unsuccessfulattempts to cut down or control use

96%

A great deal of time spent in activities necessaryto get, use, or recover from the effects of MJ

83%

Important social, occupational or recreationalactivities given up because of MJ use

64%

Marijuana Dependence Symptoms Endorsed at Baseline, cont. (N=450)

Symptom

Continued use despite knowledge of apsychological or physical problem caused orexacerbated by MJ use

95%

The need for markedly increased amounts of MJto achieve the desired effect (tolerance)

68%

Experienced withdrawal Appetite disturbance Sleep disturbance Night sweats Headaches Irritability

78%

Marijuana Related Problems Endorsed at Baseline (N=450)

Marijuana Related Problems

Feeling bad about marijuana use 90%

To have lower energy level 86%

To procrastinate 86%

Memory loss 76%

To have lower productivity 75%

Lowered self-esteem 74%

To lack self confidence 68%

Marijuana Related Problems Endorsed at Baseline, cont. (N=450)

Marijuana Related Problems

Problems between you and your partner 58%

Financial difficulties 49%

Difficulty sleeping 46%

Problems with your family 44%

To neglect your family 38%

Medical problems 34%

Problems between you and your friends 26%

Lifetime Treatment History Reported at Baseline (N=450)

Number of TimesTreated in Lifetime

% Mean(SD)

Drug Abuse012

3 or >

82%12% 2% 4%

.31(.94)

Alcohol Abuse012

93% 4% 3%

.17(.96)

Number of Days of Marijuana Use in the Past 90 Days - Baseline (N=450)

Number of Days Smoked Marijuana in the Past 90 Days

90.0

85.0

80.0

75.0

70.0

65.0

60.0

55.0

50.0

45.0

40.0

35.0

30.0

25.0

Fre

quen

cy200

175

150

125

100

75

50

25

0

Mean = 80.0SD = 14.6

Number of Joints Smoked Per Day in the Past 90 Days - Baseline (N=450)

Number of Joints Smoked per Day in Last 90 Days

18.016.014.012.010.08.06.04.02.00.0

Fre

quen

cy200

175

150

125

100

75

50

25

0

Mean = 2.9SD = 2.3

Number of Hours High Per Day in the Past 90 Days - Baseline (N=450)

Number of Hours Felt High in the Past 90 Days

25.022.520.017.515.012.510.07.55.02.50.0

Fre

quen

cy

175

150

125

100

75

50

25

0

Mean = 6.6SD = 4.6

Number of Marijuana Dependence Symptoms Endorsed in the Past 90 Days - Baseline (N=450)

Number of Marijuana Dependence Symptoms Endorsed

7.06.05.04.03.02.0

Fre

quen

cy

160

140

120

100

80

60

40

20

0

Mean = 5.6SD = 1.3

Number of Marijuana Related Problems Endorsed on the MPS - Baseline (N=450)

Number of Marijuana-Related Problems (of 19)

20.017.515.012.510.07.55.02.50.0

Fre

quen

cy160

140

120

100

80

60

40

20

0

Mean = 9.6SD.= 3.6

Marijuana Use Within 1 Hour Prior to Driving in the Past 90 Days - Baseline (N=450)

Marijuana Used Within 1 Hour Prior to Driving

Daily/Almost Daily

Less than Daily

Weekly

Less than Weekly

Never

Per

cent

60

50

40

30

20

10

0

Marijuana Use Within One Hour Prior to Working on a Paid Job in the Past 90 Days - Baseline (N=373)

Marijuana Used Within 1 Hour Prior to Working

Daily/Almost Daily

Less than Daily

Weekly

Less than Weekly

Never

Per

cent

50

40

30

20

10

0

MTP Treatment Attendance (N=450)

Number of Sessions % Brief % Extended

0 6.8 8.31 21.2 7.12 71.9 6.43 7.14 5.15 5.16 4.57 4.58 9.69 42.3

Mean Sessions Attended(SD)

1.65(.61)

6.03(3.31)

6

MTP Follow-up Rates

Post Treatment Follow-up Rate 88%

4-Month Rates:Follow-upCollateralUrine

89%100%86%

9-Month Rates:Follow-upCollateralUrine

87%100%81%

15-Month Follow-up Rate 82%

21-Month Follow-up Rate 77%

Participants Lost to 4-month Follow-up

Variable FollowedParticipants

(N=398)

Follow-upDrop-outs

(N=52)

X2

% Treatment AssignBTDTCET

32.234.433.4

34.621.244.2

NS

% SexMaleFemale

67.832.2

73.126.9

NS

% EthnicWhiteBlackHispanic

72.112.715.2

54.99.8

35.3

12.58***

Participants Lost to 4-month Follow-up, cont.

Variable FollowedParticipants

(N=398)

Follow-upDrop-outs

(N=52)

t

Mean MarijuanaSeverity Score

9.57 9.75 NS

Proportion of days smoked(of last 90 at baseline)

88 89 NS

Education 14.2 14.3 NS

Age 36.3 34.4 NS

Treatment by Time (Baseline, Week 1- Week 16) % of days smoked marijuana per week (N=398)

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

% o

f D

ays

Sm

oked

per

Wee

k

DTCBTET

Treatment by Time (BL, Wk1, Wk5, Wk12, Wk16) % of days smoked marijuana per week (N=398)

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

BL 1st Tx End BT End ET 4-Mo F/up

% o

f D

ays

Sm

oked

per

Wee

k

DTCBTET

Intention to Treat Analysis (N=450) Treatment by Time (BL, Wk1, Wk5, Wk12, Wk16) % of days smoked marijuana per week

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

BL 1st Tx End BT End ET 4-Mo F/up

% o

f D

ays

Sm

oked

per

Wee

k

DTCBTET

Treatment by Time (Baseline, 4-Month Follow-up) SCID Dependence Symptoms (N=398)

0

1

2

3

4

5

6

7

Baseline 4-Month

SC

ID D

epen

denc

e S

ympt

oms

DTCBTET

Treatment by Time (Baseline, 4-Month Follow-up) Marijuana Problem Scale (N=398)

5

6

7

8

9

10

11

Baseline 4-Month

Num

ber

of P

robl

ems

End

orse

d

BTDTCET

Products and Anticipated Accomplishments of MTP

New findings on the clinical characteristics of chronic marijuana users

New findings on the effectiveness of brief treatments of marijuana dependence

New assessment instrumentsNew treatment interventionsTreatment manuals for therapists and primary care

practitionersEdited volume of scholarly papers

Research Implications

Development and validation of screening tests and referral procedures

Evaluation of primary care applications of MET brief intervention

Evaluation of brief and extended treatments in CD/behavioral health provider network outpatient settings in terms of

ImplementationEffectivenessCost-effectiveness

Unfinished Business

Cost effectiveness studyTraining package covering:

Assessment Diagnosis Therapist skills System issues

Long-term outcome evaluation